According to foreign reports, bidi vapor, the manufacturer of bidi stick closed system, announced yesterday that it had received the PMTA acceptance letter from the regulatory agency after submitting the PMTA application to FDA on September 8, 2020.
Niraj Patel, President and CEO of bidi vapor and kaival brands, said: 'it has always been our goal to provide an option for traditional combustible tobacco to meet the needs of every adult smoker aged 21 and over. "We are very pleased that we have taken another step towards this goal.
The company is now waiting for a filing letter from the FDA. Bidi stick PMTA will then enter the substantive review phase, where it will analyze scientific data.
Bidi stick is the fastest growing closed-end e-cigarette product in the United States, according to Goldman Sachs' Stock Research Report on Nielsen data of total nicotine in 2020.
According to Nielsen data, bidi stick is the second largest disposable electronic nicotine product, mainly based on the retail volume based delivery system (ends) during the first 52 cycles.
The acceptance covers all 11 flavors in the bidi stick range.
As we move into the filing phase of the PMTA, we expect that as we move into the substantive review phase of the PMTA process, we will spend months of massive data collection, investment and hard work to collect 285000 pages of science based evidence, Patel said. Receiving the acceptance letter is an important step as we wait for the FDA's filing letter and then conduct a substantive review of our products.
Bidi stick is also the only e-cigarette product on the market with an eco-friendly, large-scale recycling program for adults, the press release said.
Kaival brands also recently launched bidi vapor's bidi pouch, a smokeless nicotine bag.