Bidi Vapor Advances to Final Substantive Review Phase of the FDA PMTA Process for all 11 Bidi® Stick Flavors
Kaival Brands Innovations Group (OTCQB: KAVL) announced that its exclusive distributor, Bidi Vapor, has advanced to the final substantive review phase of the FDA's Premarket Tobacco Product Application (PMTA) for the Bidi® Stick, a leading vaping product in the U.S. This milestone follows the successful completion of previous application stages, indicating the product meets FDA's baseline criteria. Bidi Vapor has also partnered with goPuff as its exclusive online retailer, discontinuing direct-to-consumer sales to enhance age verification and combat counterfeit products. The company emphasizes its commitment to responsible marketing and environmental sustainability.
- Bidi Vapor advanced to the final substantive review phase of the FDA's PMTA process, crucial for product approval.
- The partnership with goPuff enhances online sales distribution and ensures compliance with age verification standards.
- Bidi Vapor's commitment to sustainability through the Bidi® Cares recycling program aligns with growing consumer preferences.
- Discontinuing direct-to-consumer sales could limit customer access to Bidi® Stick, potentially affecting short-term sales.
GRANT, Fla., Feb. 24, 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 vape product on the market with an ecologically friendly, mass-recycling program called Bidi® Cares.
Bidi® Vapor, LLC, announced today it received a Premarket Tobacco Product Application (PMTA) filing letter from the U.S. Food and Drug Administration (FDA) for its family of disposable e-cigarettes called Bidi® Stick, which comes in 11 flavor varieties. The Filing Letter was the last hurdle before advancing to the final phase of the PMTA process, the Substantive Review.
Bidi Vapor has now successfully completed the first and second step of the process, initially submitting its PMTA on September 8, 2020, a day before the official deadline. On February 9, 2021, the company received an acceptance letter from the FDA, which was the first step. Now having received the filing letter, the application has met the Agency's baseline criteria to move onto the third and final phase, called the "substantive" or "scientific review" portion of the PMTA process.
"Seeking an order for the continued marketing of Bidi® Sticks in the United States is a long process. But it was always our goal to provide a premium vaping experience and an option to traditional, combustible tobacco that meets the needs of every adult smoker," said Niraj Patel, the president and CEO of Kaival Brands. "We couldn't be more pleased that we are one step closer to achieving this goal."
Kaival Brands officials are hopeful that once the FDA establishes that the Bidi® Stick meets the "appropriate for the protection of the public health" criteria established in the Tobacco Control Act, the Agency will issue marketing orders that authorize the continued marketing and sale of the Bidi® Stick disposable e-cigarettes in the United States.
"This substantive review phase is where months of extensive information collection and hard work gathering together 285,000 pages of science-based evidence will pay off, as we continually put consumer health and the environment first," Patel concluded.
With the company's desire to always exceed federal guidelines, and in response to federal efforts to curb underage access to vaping devices, Bidi Vapor announced they have discontinued their own online direct-to-consumer ("DTC") sales of its popular, premium-quality disposable vape pen, the Bidi® Stick through its website as of February 22, 2021. While Bidi Vapor believes its online age verification program for DTC sales was the most stringent program industry wide, Kaival Brands, in coordination with Bidi Vapor, has selected goPuff as the exclusive, online direct-to-consumer marketer for all of Bid Vapor's products. With a long history of distribution of alcoholic beverages, goPuff has pioneered a very stringent and dynamic compliance program and age-gating process, which Kaival Brands and Bidi Vapor endorse.
"We are extremely excited to partner with one of the fastest growing and most secure online delivery services in the country," stated Kaival Brands' Chief Executive Officer, Niraj Patel. "More importantly, goPuff's commitment to protecting minors and stringent procedural implementations will allow Kaival Brands to focus on our rapidly developing additional wholesaler distribution agreements."
goPuff, like Kaival Brands, experienced significant growth in 2020. Having raised
While Kaival Brands will continue its business-to-business (B2B) online sales to retailers, it believes its decision to halt online DTC sales specifically through www.bidivapor.com will set an example for the industry and help reduce the larger problem of underage access to vaping devices. The decision also bolsters its commitment to brick-and-mortar retail, which Kaival Brands believes to be a stronger age-verification distribution model than online sales. Kaival Brands requires brick-and-mortar partners to sign a Retailer Pledge and has produced training videos for all authorized sellers of Bidi Vapor products. Kaival Brands also has a mystery shopper program to better address retailer compliance with its age-verification policies.
"Throughout the ongoing COVID-19 pandemic, minors are switching to online sources for products, which are less likely to enforce strict, age-verification policies," said Mr. Patel. "We've seen a lot of bad actors online. Recently, Bidi Vapor had to obtain restraining orders to prevent over 30 online retailers from selling counterfeit Bidi Vapor products."
Kaival Brands will never knowingly sell Bidi Vapor products online to minors, or through physical retail establishments to minors, and actively takes steps to halt any firm attempting to sell counterfeit products to minors. In addition to concerns over underage access, Mr. Patel said the time and expense required to battle counterfeit sales also contributed to the Company's decision. "Discontinuing online sales from Bidi Vapor's website makes it easier for our online customers to know they are receiving authentic Bidi Vapor products. Now authentic Bidi Vapor online products can only be found at goPuff.com, all others offered online are fake."
On December 27, 2020, Congress passed the Preventing Online Sales of E-Cigarettes to Children Act, which amended the Prevent All Cigarette Trafficking (the "PACT") Act, which will soon prohibit the delivery of ENDS through the U. S. Postal Service, except under very limited circumstances. The Company fully supports the PACT Act and its objectives.
Based in Melbourne, Florida, 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. Bidi Vapor is also adamant about strict compliance with all federal, state, and local guidelines and regulations.
For more information, visit www.bidivapor.com.
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.
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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