Bidi Vapor receives US FDA nod for PMTA moves to next phase
After submitting a highly comprehensive report with 250,000 pages, BIDI Vapor’s application for the 11 flavors of the BIDI® Stick now moves on to the Filing Review Phase.
BIDI Vapor’s Premarket Tobacco Application (PMTA) for the 11 variants of the BIDI® Stick now moves to the Filing Review phase after BIDI Vapor received an acceptance letter from the U.S. Food and Drug Administration (FDA).
In this phase, the PMTA will undergo scrutiny by the FDA.
BIDI Vapor submitted 250,000 pages of comprehensive and detailed data contained in the PMTA. This application is probably one of the most robust among all disposable e-cigarette manufacturers across the United States.
After months of waiting, BIDI Vapor is extremely pleased to make known that it has finally received the acceptance letter from the US Food and Drug Administration (FDA) on February 8, 2021. This letter signifies that its overall PMTA application meets statutory and regulatory requirements and falls under the Center for Tobacco Products jurisdiction. Moreover, this also means that the application proceeded now to “Filing Review” and is now a step closer to the FDA’s baseline criteria called the “Substantive Review” phase.
Under the Substantive Review phase, this means the FDA will determine whether the BIDI® Stick variants meet the required standards when marketing the products “is appropriate for the protection of public health.”
The Robust Application
BIDI Vapor’s massive PMTA Application is a compilation of science-based evidence that proves that BIDI® Sticks are Appropriate for the Protection of Public Health (APPH). It consists of detailed data about the 11 flavors of the premium BIDI® Stick, with 6% nicotine weight/volume as part of its e-liquid formulation.
The company detailed its patented technology to engineer the disposable device with strict quality control standards, from the purchase of raw chemicals down to its stringent manufacturing in a cGMP (current Good Manufacturing Process) facility and toxicity testing analyses in ISO 17025 certified laboratories. The application also included BIDI Vapor’s three independent and one “combined” consumer survey with respondents consisting of people 21 years old and above.
Why is the PMTA Important?
The US FDA issued the PMTA requirement for Electronic Nicotine Delivery Systems (ENDS) manufacturers mainly for public health reasons. According to its website, they evaluate PMTA applications according to product risks and benefits to the general population. The submissions are also assessed if the product would replace presently used tobacco products or promote new usage to current non-users.
On the part of ENDS manufacturers, the PMTA is also a highly demanding and expensive process. Every variant of the product must have its separate application, which can be costly, especially for small-time vape brands. Unfortunately, a brand’s failure to submit an application and have it approved will mean that it must stop selling its product. Since the deadline last year, the FDA has sent warnings to 10 vape brands that did not file for a PMTA application.
BIDI Vapor Rises Up to the Challenge
Niraj Patel, CEO of BIDI Vapor, believes and supports that proper regulations must be in place for all ENDS Products, including manufacturing, safety, and marketing. He is willing for BIDI Vapor to work with the FDA and adhere to its policies based on science and facts, especially if it means protecting the public’s welfare.
“It has always been our goal to provide a premium vape experience as an option to traditional, combustible tobacco that meets the needs of every adult smoker, age 21 and older. We couldn’t be more pleased that we are one step further in achieving this goal,” says Patel. “We are confident that, upon review, the FDA will authorize BIDI Vapor’s BIDI® Stick for continued marketing in the United States,” he added.
A Sincere Cause Always Prevails
Despite the intimidating requirements that the FDA has imposed, BIDI Vapor understands the essence behind the process. After all, the BIDI® Stick was created side-by-side with substantial advocacies for public services, such as its stringent Youth Access Prevention Program to fight underage vaping and its multi-level Anti-Catfish Campaign to protect consumers from counterfeit products. The company also had the environment in mind during the BIDI® Stick’s creation and established the BIDI® Cares Program as a result.
With the causes that the company invests in, the BIDI® Stick’s PMTA application’s progress is a big win for its partners and the youth it sincerely protects. PMTA or not, BIDI® Vapor has set out to change the vaping game, offer a premium product, and give adult vapers the BIDI® experience for them to remember and cherish.