Kaival Brands Innovations Group, Inc. announced that the U.S. Court of Appeals for the 11th Circuit has ruled 2-to-1 in Bidi Vapor’s favor, granting its petition for review. The decision set aside and remanded as arbitrary and capricious the U.S. Food and Drug Administration’s (FDA) order denying the Premarket Tobacco Product Applications (PMTA) for the non-tobacco flavored BIDI Sticks.
On Aug. 23, 2022, the 11th Circuit held that FDA’s marketing denial order (MDO) issued against Bidi Vapor’s non-tobacco flavored ENDS devices was “arbitrary and capricious,” primarily because FDA failed to consider the relevant marketing and sales-access-restrictions plans included in Bidi Vapor’s comprehensive PMTAs.
“Distribution in the ENDS market has been challenging to say the least, especially regarding compliance with FDA policies and procedures. As the exclusive U.S. distributor of Bidi Vapor’s products, this is a significant event for us and our downstream partners, as many awaited the decision before expanding distribution, and paves the way for potential revenue growth for our company,” said Eric Mosser, president and chief operating officer of Kaival Brands. “But more than that, we are glad the appellate court recognized the potential importance and direct effects that an adult-focused marketing plan and strict sales and access restrictions may have on addressing the youth access problem.
“We strongly believe that the appeal to and illegal usage by youth can be significantly reduced, not by banning flavors which are necessary for adult smokers seeking non-combustible alternatives to cigarettes, but with responsible marketing, adult-oriented packaging, restrictive online access and enforcement of the current laws and regulations to force out bad actors marketing illegal and counterfeit products.”
In the majority opinion, the Court stated that FDA needed to consider relevant marketing strategies and plans surrounding access and restrictions around minors included in the PMTAs, and not simply disregard those plans as historically insufficient.
While the majority focused on FDA’s failure to review Bidi’s marketing plans and sales and access restrictions, the majority further noted, with respect to Bidi Vapor’s applications, that FDA also failed to consider key evidence including, among other things, “product information; scientific safety testing; literature reviews; consumer insight surveys; and details about the company’s youth access prevention measures, distribution channels and adult-focused marketing practices,” which “target only existing adult vapor product users, including current adult smokers,” as well as Bidi Vapor’s anti-counterfeit authentication system and retailer monitoring program.
The FDA could appeal the ruling or put Bidi Vapor’s PMTAs for its non-tobacco flavored devices into scientific review. The Court ruling “remands,” or sends, the applications back to the FDA for action. The dissenting judge sided with FDA and its arguments that it has not seen any marketing or access plans that would reduce youth access, or that non-tobacco flavored vaping products offer an advantage over tobacco-flavored vaping products in decreasing smoking among existing smokers.
“We believe that Bidi Vapor has provided FDA with substantial, robust and reliable scientific evidence through, among other things, surveys, behavioral studies and clinical trials on our BIDI Stick products. We are confident the science will prove that the BIDI Stick is appropriate for public health (APPH),” noted Kaival Brands Chief Science Officer and Founder Niraj Patel. “Following on FDA’s initial administrative stay of the MDO, we believed that the subsequent judicial stay was a good indication that the Court found some merit in Bidi Vapor’s arguments and puts Bidi Vapor’s PMTAs for the non-tobacco flavored ENDS one step closer to being properly and fully evaluated by the FDA. Bidi Vapor’s victory in our merits case confirms our prior beliefs. We look forward to cooperating with the agency through the scientific review process.”
Patel owns and controls Bidi Vapor. As a result, Bidi Vapor and Kaival Brands are considered under common control and Bidi Vapor is considered a related party.
Based in Grant, Fla., 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 develop internally, acquire, own or exclusively distribute these innovative products and grow each into dominant market-share brands with superior quality and recognizable innovation. Kaival Brands and Philip Morris International Inc. are the exclusive global distributors of products manufactured by Bidi Vapor.