Hear about court decision to set aside MDO; licensing agreement with PMI

LAS VEGAS — Representatives of Bidi Vapor, LLC, makers of the BIDI^® Stick electronic nicotine delivery system (ENDS), will speak at the NACS Show about a recent court decision setting aside the marketing denial order (MDO) against its non-tobacco flavored products.

The Bidi Vapor team will be in Booth No. 3204, North Hall, Level 1, October 2-4, in the Las Vegas Convention Center at the 2022 NACS Show.

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 had 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.