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® Stick in partnership with BIDI® Vapor, LLC.
PMTA Application Details
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.
“Both Kaival Brands and BIDI® Vapor fully support proper regulation of the category so that all ENDS products meet the highest manufacturing, safety and marketing standards for adult smokers, with the ultimate goal of improving the public health,” said Niraj Patel, president, and CEO of Kaival Brands. “We look forward to working with BIDI® Vapor as they work with the FDA to construct its regulatory policy based on science and facts.”
“We are confident that, upon review, the FDA will authorize BIDI® Vapor’s BIDI® Stick for continued marketing in the United States,” Patel added. “It is a premium-quality product that adult smokers have discovered can be a viable alternative to combustible tobacco, and we look forward to meeting the increasing market demand for the innovative BIDI® Stick.”
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The BIDI® Stick is manufactured by BIDI® Vapor, LLC, and the Company acts as the sole exclusive worldwide distributor. Mr. Patel, the Company’s president, chief executive officer, and chief financial officer, owns and controls BIDI® Vapor, LLC; thus, BIDI® Vapor, LLC, and the Company are considered under common control, and BIDI® Vapor, LLC is considered a related party.
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