Kaival Brands Innovations Group Inc., the exclusive global distributor of all products manufactured by Bidi Vapor, announced that it received the FDA’s PMTA acceptance letter and notes the overall application is one step closer to meeting the agency’s baseline criteria for review before moving onto the final phase of the PMTA process.
Bidi Vapor’s primary offering, the tamper-resistant Bidi Stick, is the only adult-focused vape product on the market with an ecologically friendly, mass-recycling program. Kaival Brands also recently launched Bidi Vapor ‘s Bidi Pouch, a tobacco-free nicotine pouch.
“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,” said Niraj Patel, the president and CEO of Bidi Vapor and Kaival Brands, Melbourne, Fla. “We couldn’t be more pleased that we are one step further in achieving this goal.”
The acceptance letter covers all 11 flavors in the Bidi Stick family of products, as detailed in Bidi Vapor’s PMTA submission, Patel said. “We look forward to working with FDA during the filing and substantive review of the PMTAs, and further demonstrating the uncompromising product quality Bidi® Vapor brings, as evidenced by our recent distribution announcement with H.T. Hackney,” says Eric Mosser, COO, Kaival Brands. “Moving to the filing and, we anticipate, to the substantive review phase of the PMTA process is where our months of extensive data collection, investment and hard work assembling 285,000 pages of science-based evidence will pay off,” Patel concluded. “Receipt of the acceptance letter is a major step, as we await the FDA’s filing letter and then substantive review of our products.”
Bidi Vapor has always assumed responsibility to the communities it serves. Bidi Vapor and Kaival Brands displayed their steadfast commitment to community and integrity by recently engaging in a complete overhaul in packaging, branding and labeling of the product to go above and beyond the industry standards and FDA guidelines and requirements.
Bidi Vapor maintains a commitment to responsible marketing, supporting age-verification standards and sustainability through its Bidi Cares recycling program. The company’s premiere device, the Bidi Stick, is a premium product made with medical-grade components, a UL-certified battery and technology designed to deliver a consistent vaping experience for adult smokers. Bidi Vapor is also adamant about compliance with all federal, state, and local guidelines and regulations.
Kaival Brands Innovations Group, Inc., Grant, Fla., is a company focused on growing and incubating innovative and profitable products into mature and dominant brands in their respective markets.
Its vision is to develop internally, acquire, own or exclusively distribute these innovative products and grow each into dominant market-share brands with superior quality and recognizable innovation.