Kaival Brands, the U.S. distributor of products manufactured by Bidi Vapor, expects an increase in sales of their Bidi Stick vapor product following a recent court ruling in the United States. The U.S. Food and Drug Administration (FDA) will be revisiting the pre-market tobacco product application (PMTA) for the company.
On August 23rd, six companies, including Bidi Vapor and Diamond Vapor, filed a petition for review with the 11th Circuit Court of Appeals, questioning the FDA's rejection of their e-cigarette applications. According to Chief Judge William Pryor, the agency failed to properly evaluate these companies' marketing and sales access restriction plans aimed at minimizing youth exposure and access.
This ruling effectively overturns the order to cease marketing and allows Bidi Vapor to continue selling all flavor varieties of Bidi Stick in the United States. The company submitted PMTA for all 11 Bidi Stick flavors prior to September. The PMTA deadline was on September 9, 2020.
Eric Mosser, President and Chief Operating Officer of Kaival Brands, announced that the decision to become the exclusive distributor of Bidi Vapor products in the United States is a significant milestone for the company and its downstream partners. This decision paves the way for potential revenue growth and many have been eagerly awaiting the expansion of distribution.
But not only that, we are pleased that the appellate court recognizes the potential importance and direct impact of marketing programs focused on adults and strict sales and access restrictions in addressing youth access issues.
At the time of publication, the FDA had not announced how they will respond to the court ruling. The agency may appeal the decision or conduct a scientific review of Bidi Vapor's non-tobacco flavored devices' PMTA.
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