Kaival Brands Innovations Group, Inc. (OTC

KAVL) Announces PMTA Submission by Bidi Vapor

Kaival Brands is the sole worldwide exclusive distributor for the Bidi Stick

GRANT, Fla., Sept. 08, 2020 (GLOBE NEWSWIRE) -- via NetworkWire – Kaival Brands Innovations Group, Inc. (OTCQB: KAVL) (“Kaival Brands,” the “Company” or “we”), a company focused on growing and incubating innovative and profitable products into mature, dominant brands, is proud to announce that Bidi Vapor, LLC, manufacturer of the disposable vape pen called Bidi Stick, has submitted its Premarket Tobacco Product application (PMTA) to the U.S. Food and Drug Administration (FDA), Center for Tobacco Products, for review. The deadline for PMTA submissions is Sept. 9, 2020. The Company acts as the sole exclusive worldwide distributor of the Bidi^TM Stick in partnership with Bidi^TM Vapor, LLC.

The application detailed 11 flavored varieties with nicotine concentrations of 6% weight/volume as part of the company’s proprietary e-liquid formulation. Starting from a science-based foundation, Bidi Vapor has engineered its electronic nicotine-delivery system (ENDS) products using its own patented technology, ensuring quality control and assurance from the raw chemicals and components purchased through to the manufacturing process in a cGMP (current Good Manufacturing Practice) facility. The product then goes through various in-vitro and in-vivo toxicity testing (including genotoxicity tests) at a GLP (Good Laboratory Practice) approved lab, as well as HPHC (Harmful and Potentially Harmful Constituents) analysis of both the aerosol and e-liquid in ISO 17025 certified labs. Also included in its PMTA submission, Bidi Vapor conducted three independent surveys and one “combined” consumer survey of people aged 21 and over.

Possibly the largest submission compiled across all ENDS manufacturers, Bidi Vapor’s application runs over 285,000 pages, providing science-based evidence demonstrating that Bidi Sticks are Appropriate for the Protection of Public Health (APPH). The applications further support the public need to provide options to adult smokers of combustible tobacco products. The PMTA process will allow the FDA to review ENDS from individual manufacturers to potentially authorize continued marketing in the United States, officials with Bidi Vapor stated.