We are happy to announce that Bidi Vapor has been granted a stay order by the FDA.
Which means all 11 flavors of the BIDI®️ Stick are now legal to market and distribute as the FDA is currently reviewing the previously released MDO.
LAS VEGAS — Representatives of Bidi Vapor, LLC, makers of the BIDI® Stick electronic nicotine delivery system (ENDS), spoke at the NACS Show about a recent court decision setting aside the marketing denial order (MDO) against its non-tobacco flavored products.
The 2022 NACS Show was held in Las Vegas, Oct. 1-4, 2022.
This past August, Kaival Brands Innovations Group Inc., the U.S. distributor of Bidi Vapor products, announced that the U.S. Court of Appeals for the Eleventh Circuit has ruled 2-1 in Bidi Vapor’s favor, granting its petition for review, and setting aside and remanding as arbitrary and capricious the U.S. Food and Drug Administration (FDA) order denying the Premarket Tobacco Product Applications (PMTAs) for its non-tobacco flavored BIDI® Sticks.
At the time of Kaival’s news release, FDA has not announced its plans moving forward. The agency 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.
In other Bidi Vapor news, Kaival Brand’s recently formed, wholly owned subsidiary, Kaival Brands International, LLC (“KBI”), entered into an international licensing agreement with Philip Morris Products S.A. (PMPSA) on June 13, 2022. The International Agreement grants to PMPSA a license of certain intellectual property rights relating to Bidi Vapor’s premium ENDS device, known as the BIDI® Stick in the U.S., as well as potentially newly developed devices, to permit PMPSA to manufacture, promote, sell and distribute such ENDS device and newly developed devices, in international markets, outside of the U.S. The parties believe this agreement promotes their joint vision of a smoke-free future.
Kaival Brands also reported on the launch of PMI’s custom-branded self-contained e-vapor product, VEEBA, in Canada. The product, a self-contained e-vapor device, has been custom developed and is now being distributed in Canada, pursuant to the licensing agreement. The agreement covers the development, licensing and distribution of ENDS products in certain markets outside of the United States, pending further regulatory assessments.
ABOUT BIDI VAPOR
Based in Melbourne, Florida, Bidi Vapor maintains a commitment to responsible adult-focused marketing, strict youth access prevention measures and age-verification standards, as well as sustainability through its BIDI® Cares recycling program. Bidi Vapor’s device, the BIDI® Stick, is a premium product made with high-quality components, a UL-certified battery and technology designed to deliver a consistent vaping experience for adult smokers 21 and over. Bidi Vapor is also adamant about strict compliance with all federal, state and local guidelines and regulations. At Bidi Vapor, innovation is key to its mission, with the BIDI® Stick promoting environmental sustainability, while providing a unique vaping experience to adult smokers.