Bidi Vapor Receives Review Request

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Decision on Bidi Vapor’s tobacco-free ENDS devices gives Kaival Brands hope for revenue growth.

Kaival Marques Innovations Group, Inc. announced that the United States Court of Appeals for the 11th Circuit had ruled 2 to 1 in Bidi Vapor’s favour, granting his motion for review. The decision overturned and dismissed as arbitrary and capricious the US Food and Drug Administration (FDA) order denying premarket tobacco product applications (PMTAs) for unflavored BIDI sticks.

On August 23, 2022, the 11th Circuit ruled that the FDA’s marketing denial order (MDO) issued against Bidi Vapor’s non-tobacco flavored ENDS devices was “arbitrary and capricious”, primarily because the FDA had not considered relevant marketing and trade access. restrictions plans included in Bidi Vapor’s full PMTAs.

“Distribution into the ENDS market has been challenging to say the least, particularly with respect to compliance with FDA policies and procedures. As the exclusive US distributor of Bidi Vapor’s products, this is an event important to us and our downstream partners, as many were awaiting the decision before expanding distribution, and paves the way for potential revenue growth for our company,” said Eric Mosser, President and Chief Executive Officer. operation of Kaival Brands.” But more than that, we are pleased that the Court of Appeal recognized the potential importance and direct effects that an adult-focused marketing plan and strict sales and access restrictions may have on solving the youth access problem.

“We strongly believe that the appeal and illegal use by young people can be significantly reduced, not by banning flavors that are necessary for adult smokers seeking non-combustible alternatives to cigarettes, but with responsible marketing, adult-targeted packaging, restrictive online access, and enforcement of applicable laws and regulations to weed out bad actors marketing illegal and counterfeit products.

In the majority opinion, the court said the FDA should review relevant marketing strategies and plans regarding access and restrictions for minors included in PMTAs, not simply ignore those plans as historically inadequate.

While the majority focused on the FDA’s failure to review Bidi’s marketing plans and sale and access restrictions, the majority further noted, with respect to Bidi’s claims Vapor, that the FDA also failed to consider key evidence, including, among other things, “product information; scientific safety tests; literary journals; consumer surveys; and details of the company’s youth access prevention measures, distribution channels and adult-focused marketing practices”, which “target only existing adult users of vaping products, including Current Adult Smokers”, as well as Bidi Vapor’s Anti-Counterfeit Authentication System and Retailer Monitoring Program. .

The FDA could appeal the decision or subject Bidi Vapor’s PMTAs for its tobacco-free flavored devices to scientific review. The Court’s decision “remits” or returns the claims to the FDA for action. The dissenting judge sided with the FDA and its arguments that he saw no marketing or access plans that would reduce youth access, or that vaping products without tobacco flavor offer an advantage over tobacco-flavored vaping products in reducing smoking among existing smokers.

“We believe that Bidi Vapor has provided the FDA with substantial, strong, and reliable scientific evidence through, among other things, surveys, behavioral studies, and clinical trials of our BIDI Stick products. We are confident that science will prove that the BIDI Stick is appropriate for public health (APPH),” said Chief Scientific Officer and Founder of Kaival Brands, Niraj Patel. “Following the initial administrative stay of the MDO by the FDA, we felt that the subsequent judicial stay was a good indication that the Court found some merit in Bidi Vapor’s arguments and put Bidi Vapor’s PMTAs for ENDS without tobacco flavor one step closer to being properly and fully reviewed by the FDA. Bidi Vapor’s victory in our merits case confirms our earlier beliefs. We look forward to cooperating with the agency throughout the review process. scientific.

Patel owns and controls Bidi Vapor. Therefore, the Bidi Vapor and Kaival brands are considered to be under common control and Bidi Vapor is considered a related party.

Based in Grant, Florida, Kaival Brands is a company focused on growing and incubating innovative and profitable products into mature and dominant brands in their respective markets. Its vision is to in-house develop, acquire, own or exclusively distribute these innovative products and make each market leading brands with superior quality and recognizable innovation. Kaival Brands and Philip Morris International Inc. are the exclusive worldwide distributors of products manufactured by Bidi Vapor.

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