Bidi Vapor Submits Premarket Tobacco Applications to FDA for the BIDI Stick
After months of extensive information collection and hard work, Bidi Vapor seeks an order to authorize the marketing of the BIDI® Stick.
MELBOURNE, Fla. September 8, 2020—Bidi Vapor has submitted a group of premarket tobacco applications to the U.S. Food and Drug Administration (FDA) for the BIDI® Stick. A grant of these orders would allow these products to stay on the market after September 9, 2020, the FDA’s deadline.
BIDI® Stick, a disposable vape pen, comes in a nicotine concentration of 6% weight/volume. Over 285,000 pages submission bundled the 11 flavor varieties of BIDI® Stick, highlighting its science-based evidence that it is appropriate for protecting public health. The applications include a range of scientific studies, three independent and one “combined” consumer surveys, in-vitro and in-vivo toxicity testing, and HPHC (Harmful and Potentially Harmful Constituents) aerosol and e-liquids tests.
“To get approval to market the BIDI® Stick, we make sure that our PMTA submission was based on science and facts,” said Niraj Patel, the president and CEO of Bidi Vapor. “It is our mission to provide a premium product for adults 21 years and over through responsible business practices that ensure we do not attract youth.”
Bidi Vapor implemented these Youth Access Prevention Measures to ensure that no underage individuals can gain access to the BIDI® Stick:
- Age-gated website. Visitors of the website must input their date of birth first before gaining access to the website.
- Discontinuation of -direct-to-consumer services. Bidi Vapor products can no longer be purchased through our websites. Our online shop has been shutdown to bolster our efforts for youth prevention. We partnered with GoPuff, which allows age-verified adults to have BIDI® Sticks delivered from local retailers. Agreement between direct retailers and Bidi Vapor through the Retailer’s Pledge to ensure compliance with age-verification policies at the retail level.
- Aside from its youth prevention efforts, Bidi Vapor also offers our adult consumers the option to recycle the used and empty BIDI®️ Sticks through the BIDI® Cares campaign. Since the BIDI® Stick was developed using recyclable components, Bidi Vapor encourages its consumers to return at least ten empty devices for a free one on their next purchase.
Responsible marketing and good manufacturing processes—these are the pillars of Bidi Vapor.
“We built our PMTAs based on science, research, and data, and we are confident that the FDA will authorize the BIDI® Stick to stay on the market,” Niraj Patel concluded.
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At Bidi Vapor, innovation is key to our mission, with the BIDI® Stick promoting environmental sustainability while providing a unique vaping experience to adult smokers. Contributing to a smoke-free world for our future generations is in Bidi Vapor’s DNA.
Watch the video above to learn more about the BIDI® Story.