Bidi Vapor Submits Premarket Tobacco Applications to FDA for the BIDI® Stick
Maker of BIDI® Stick asks for authorization to continue marketing e-cigarettes in the U.S.
SEP 8, 2020
MELBOURNE, Fla., September 8, 2020 (Newswire.com) – Bidi Vapor, LLC, a manufacturer of the disposable vape pen called BIDI® Stick, announced that it has submitted its Premarket Tobacco Product Application (PMTA) to the U.S. Food and Drug Administration (FDA), Center for Tobacco Products, for review. The submission included a family of disposable e-cigarette products under the BIDI® Stick brand name.
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.
Included in its PMTA submission, Bidi Vapor also conducted one “combined” consumer and three independent surveys 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 the BIDI® Sticks are Appropriate for the Protection of Public Health (APPH). The application further supports the public need to provide options to adult smokers of combustible tobacco products, officials with the Melbourne, Fla.-based company said.
“Bidi Vapor fully supports 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, owner of Bidi Vapor. “We look forward to working with the FDA as it constructs its regulatory policy based on science and facts.”
In developing the BIDI® Stick for adult consumers aged 21 and over, Bidi Vapor has produced a “premium” disposable ENDS device that has medical-grade components, batteries equivalent to those in cellphones and a mouthpiece design combined with other structural components to provide a consistent vaping experience, officials said.