Bidi Vapor obtains judicial stay of FDA marketing denial order

The decision allows Bidi Vapor and Kaival Brands to continue selling 11 BIDI Stick ENDS.

Kaival Brands Innovations Group, the exclusive worldwide distributor of products manufactured by Bidi Vapor, announced that the United States Court of Appeals for the Eleventh Circuit has granted a judicial stay of the previously issued marketing denial order (MDO) by the United States Food and Drug Administration (FDA) to Bidi Vapor in September 2021.

The decision, issued on February 1, 2022, allows Bidi Vapor and Kaival Brands to market and sell all of its BIDI Stick disposable electronic nicotine delivery systems (ENDS) – which are intended exclusively for adults 21 and older – including its tobacco, menthol and flavored products. Bidi Vapor is continuing its legal action on the merits, compelling the FDA to resubmit Bidi Vapor’s Premarket Tobacco Product Application (PMTA) for flavored ENDS to scientific review.

With the judicial stay decision in favor of Bidi Vapor, Kaival Brands expects many distribution partners to restore their previous sales volumes, with potentially new distribution channels added as well.

“We expect this legal stay will result in a rebound in BIDI Stick sales,” said Niraj Patel, President and CEO of Kaival Brands and Bidi Vapor. “Many wholesale and retail partners had halted or slowed purchases of the BIDI Stick, until we heard from the courts on the likelihood of our case succeeding on the merits. This is what our wholesale and retail partners have been waiting for.

“The company believes this decision marks another step in the direction of providing adult smokers 21 and older with a viable alternative to combustible cigarettes. Distributors, wholesalers, retailers and adult consumers are all eager to see positive results not only for Bidi Vapor, but for the vaping industry as a whole. We believe in scientific regulation of ENDS and hope that the courts will require the FDA to follow the law when reviewing Bidi Vapor’s PMTAs,” Patel continued.

Bidi Vapor remains committed to regulatory compliance and the pre-market review process and is moving forward with its planned studies to support its PMTAs. Behavioral studies of Bidi Vapor show that the majority of BIDI Stick users are older smokers who have either successfully quit smoking completely or have been able to significantly reduce the number of cigarettes smoked daily. This aligns with the completed clinical pharmacokinetic (PK) study of Bidi Vapor, which demonstrates that BIDI sticks deliver nicotine to adult consumers comparable to their regular cigarette brand and also elicit similar subjective effects. In short, behavioral studies and the PK study demonstrate that BIDI Sticks can be a satisfactory alternative to cigarettes for current smokers and can help them quit smoking.

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