Bidi Vapor Submits Premarket Tobacco Application to FDA

Maker of Bidi™ Stick asks for authorization to continue marketing e-cigarettes in the U.S.

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 Bidi™ Stick as a viable option for adults smokers 21 and older, 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.

The company’s mission is to offer the adult smoker options to traditional, combustible tobacco that will meet their nicotine-delivery needs, said Patel, a Florida entrepreneur with pharmaceutical and chemical degrees. “But we are also concerned about vaping among those who are under the age of 21,” Patel said. “We believe that with the proper age-verification restrictions in place, we can meet the needs of the adult smoker while deterring underage use.”

Regarding the concern about minors possibly having access to vaping products, Bidi™ Vapor uses several stages of legal-age and identity verification with its products, including third-party verification and signature/ID requirements for online purchases and a Retailer Pledge of age-verification for brick-and-mortar stores.

Regarding its stance on sustainability, the company encourages customers to return 10 of their used devices for a free one upon their next purchase.

The PMTA process will allow the FDA to review ENDS from individual manufacturers to potentially authorize continued marketing in the United States, officials said. The deadline for PMTA submissions is Sept. 9, 2020.

“We are confident that upon review, the FDA will authorize the Bidi™ Stick for continued marketing in the United States,” Patel said. “It is a high-quality product that adult smokers have discovered can be a viable option to combustible tobacco.”

Source: Bidi™ Vapor LLC


Categories: Retail

Tags: e-cigarettes, FDA, PMTA, vaping