Kaival Brands Innovations Group, the exclusive global distributor of products manufactured by Bidi Vapor, announced that the U.S. Court of Appeals for the Eleventh Circuit has granted a judicial stay of the marketing denial order (MDO) previously issued by the U.S. Food and Drug Administration (FDA) to Bidi Vapor in September 2021.
The ruling, issued on Feb. 1, 2022, allows Bidi Vapor and Kaival Brands to market and sell all of its BIDI Stick disposable electronic nicotine delivery systems (ENDS) — which is intended exclusively for adults 21 and over — including its tobacco, menthol and flavored products. Bidi Vapor continues with its merits lawsuit compelling the FDA to place Bidi Vapor’s Premarket Tobacco Product Application (PMTA) for the flavored ENDS back under scientific review.
With the judicial stay decision going in favor of Bidi Vapor, Kaival Brands expects many distribution partners to reestablish their previous sales volumes, with potentially new distribution chains added as well.
“We expect this judicial stay will result in a rebounding of BIDI Stick sales,” said Niraj Patel, president and CEO of both Kaival Brands and Bidi Vapor. “Many wholesale and retail partners had discontinued or slowed purchases of the BIDI Stick, until we heard back from the courts on the likelihood of our merits case succeeding. This is what our wholesale and retail partners have been waiting for.”
“The company believes that this decision signals a new milestone in the path toward providing adult smokers 21 and older with a viable alternative to combustible cigarettes. Distributors, wholesalers, retailers and adult consumers are all anxious to see positive outcomes not just for Bidi Vapor, but for the vaping industry as a whole. We believe in science-based regulation of ENDS and hope the courts will require FDA to adhere to the law as it reviews Bidi Vapor’s PMTAs,” Patel continued.
Bidi Vapor remains committed to regulatory compliance and the premarket review process and is forging ahead with its planned studies to support its PMTAs. Bidi Vapor’s behavioral studies show that the majority of BIDI Stick consumers are older smokers who were either able to transition completely away from smoking or were able to significantly reduce the number of daily cigarettes smoked. This corresponds with Bidi Vapor’s completed clinical pharmacokinetic (PK) study, which demonstrates that the BIDI Sticks deliver nicotine to adult consumers comparable to their usual cigarette brand and also elicited similar subjective effects. In short, the behavioral studies and PK study demonstrate that the BIDI Sticks may be a satisfying alternative to cigarettes among current smokers and may support their transitioning away from cigarette smoking.