Bidi Vapor LLC, the manufacturer of the disposable vape pen called Bidi Stick, announced that it has submitted its Premarket Tobacco Product application (PMTA) to the 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:
- AgeChecker.net, a third-party provider that uses multiple databases to confirm the identity of an online customer.
- A call within 24 hours to the online customer to verify the purchase, as well as the person’s age and identity.
- Requiring a government identification and the signature of an adult 21 years or older upon delivery of product.
- At the retail level, Bidi Vapor requires retailers sign a Retail Pledge, designed to affirm compliance to age-verification policies that the company itself abides by.
Regarding its stance on sustainability, the company created the Bidi Cares campaign, using the slogan, “Save your Bidi. Save our Planet.” Multiple components of the product, including the battery, are recyclable, and the campaign encourages customers to return 10 of their used devices for a free one upon their next purchase.
From device design to responsible marketing to its sustainability efforts, Patel hopes to continue his family’s tradition in the nicotine and tobacco business, developing options for users 21 and older of combustible tobacco products. Patel’s family has a history in India of managing a tobacco business, where they processed and supplied tobacco leaves.
The PMTA process will allow the FDA to review ENDS from individual manufacturers to potentially authorize continued marketing in the U.S., officials said. The deadline for PMTA submissions was 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.”