- On February 1, 2022, Kaival Brands’ product partner, Bidi Vapors LLC was granted a judicial stay on the marketing denial order issued by the US FDA, enabling the company to resume sale of their products within the US market
- The legal action comes after the FDA moved to oust over 946,000 vaping products from the market through the issuance of blanket MDO’s whilst approving only 3 over the course of a year-long review
- Bidi Vapor LLC sought to contest the MDO, arguing that their near-285,000-page PMTA filing contained robust and reliable scientific data touting the benefits of their flavored BIDI(R) stick products relative to tobacco-flavored ENDS
- The company’s management believe the judicial stay will lead to a marked improvement in overall sales, with Bidi Vapor’s former distributors likely to resume prior orders
Following months of legal inertia, on February 1, 2022, the Eleventh Circuit Court of Appeals granted Bidi Vapor LLC a judicial stay on their marketing denial order (“MDO”) which was issued by the Food and Drug Administration (“FDA”) (https://ibn.fm/B65bR). In effect, the legal decision enables Bidi Vapor to continue marketing and selling their product while lawsuits remain active. Kaival Brands Innovations Group (NASDAQ: KAVL), a company dedicated towards fostering and incubating companies into mature, dominant brands and global distributor for Bidi Vapor LLC, hailed the decision which followed on from the FDA’s decision to deny and oust thousands of products from the marketplace through its new premarket tobacco product application (“PMTA”) process.
Originally conceived to determine whether a given product was “appropriate for the protection of public health” – an ambiguous concept understood to symbolize a given product’s likelihood to help adult smokers transition to safer alternatives, the FDA had set a deadline of September 2020 for vape companies to submit PMTA applications to…
NOTE TO INVESTORS: The latest news and updates relating to KAVL are available in the company’s newsroom at http://ibn.fm/KAVL
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