Bidi® Vapor Receives FDA PMTA Acceptance Letter for all 11 Bidi® Stick Products
Kaival Brands Innovations Group, Inc. (OTCQB: KAVL) announces that Bidi Vapor received an FDA PMTA acceptance letter for all 11 flavors of the Bidi Stick, marking a crucial step in the regulatory process. This acceptance allows the company to proceed towards the substantive review phase. Kaival emphasizes its commitment to responsible marketing, compliance, and sustainability through the Bidi Cares program. With a premium product aimed at adult smokers, the company aims to distinguish itself in the vaping industry.
- Receipt of FDA PMTA acceptance letter for all 11 Bidi Stick flavors, facilitating progress towards substantive review.
- Strong commitment to responsible marketing and sustainability through Bidi Cares recycling program.
- None.
MELBOURNE, Fla., Feb. 9, 2021 /PRNewswire/ -- Kaival Brands Innovations Group, Inc. (OTCQB: KAVL) ("Kaival Brands," the "Company," or "we"), is the exclusive global distributor of all products manufactured by Bidi Vapor, LLC ("Bidi Vapor"). Bidi Vapor's primary offering, the Bidi® Stick, is the fastest-growing closed system vaping product in the U.S. The tamper-resistant Bidi® Stick is also 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.
Bidi Vapor is proud to announce we have received the FDA's PMTA acceptance letter today, and note 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, which is called a "substantive review."
"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."
As the category leader, we have always assumed responsibility to the communities we serve. 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. For more information, visit www.bidivapor.com.
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.
Our 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.
Learn more about Kaival Brands Innovations Group, Inc., at www.kaivalbrands.com
Forward-Looking Statements
This press release includes statements that constitute "forward-looking statements" within the meaning of federal securities laws, which are statements other than historical facts that frequently use words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "position," "should," "strategy," "target," "will," and similar words. All forward-looking statements speak only as of the date of this press release. Although we believe that the plans, intentions, and expectations reflected in or suggested by the forward-looking statements are reasonable, there is no assurance that these plans, intentions, or expectations will be achieved. Therefore, actual outcomes and results could materially differ from what is expressed, implied, or forecasted in such statements.
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SOURCE Kaival Brands
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