Kaival Brands Innovations Group, the exclusive global distributor of all products manufactured by Bidi Vapor, announced on Monday that Bidi Vapor LLCwill appeal the U.S. Food and Drug Administration’s (FDA) decision to deny the company’s premarket tobacco product application (PMTA) for its “classic” tobacco-flavored Bidi Stick ENDS device.
On Jan. 22, the FDA issued a marketing denial order (MDO) to Bidi Vapor LLC for its Bidi Stick e-cigarette. The decision does not involve the company’s remaining 10 PMTAs for its non-tobacco flavored devices, which are still under the FDA’s scientific review.
“Those 10 products remain available for sale through Kaival Brands, subject to FDA’s enforcement discretion,” the company said in a statement.
On Jan. 26, Bidi Vapor filed a petition, in response to the FDA’s MDO, requesting that the U.S. Court of Appeals for the Eleventh Circuit review the MDO. Bidi Vapor will also be seeking a stay of the MDO pending the outcome of the litigation.
Bidi Vapor’s Niraj Patel, CEO and founder of the Melbourne, Florida-based company said “Bidi Vapor disagrees with the FDA’s decision and is taking immediate action accordingly.”
In August 2022, a federal court ruled in favor of Bidi and set aside the MDOs on its 10 non-tobacco flavored PMTAs, putting them all back into scientific review.
“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.
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