Bidi Vapor, the manufacturer of the disposable vape pen Bidi Stick, has submitted its Premarket Tobacco Product application (PMTA) to the U.S. Food and Drug Administration (FDA). The announcement was made by Kaival Brands Innovations Group, a company focused on growing and incubating innovative and profitable products into mature, dominant brands, in a press release.
“We are confident that, upon review, the FDA will authorize Bidi Vapor’s Bidi™ Stick for continued marketing in the United States,” said Niraj Patel, president and CEO of Kaival Brands. “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.”
The application detailed 11 flavored varieties with nicotine concentrations of 6 percent weight/volume. The Bidi Stick is a disposable pod system, similar to Juul. “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 release states.
Bidi states that its product went 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.
Bidi Vapor’s application was more than 285,000 pages, according to the release. “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 Patel. “We look forward to working with Bidi Vapor as they work with the FDA to construct its regulatory policy based on science and facts.”