Kaival Brands expands distribution of Bidi Vapor
This expansion represents a positive development for the company since the United States Food and Drug Administration (“FDA”) issued its marketing denial order (“MDO”) to Bidi Vapor last September, as it has made for approximately 96% of all flavored product manufacturers. ENDS. In February 2022, the United States Court of Appeals for the Eleventh Circuit granted Bidi Vapor a judicial stay of the MDO, pending resolution of the pending litigation based on Bidi Vapor’s merits. In effect, the judicial stay means that the MDO, which covered non-tobacco flavored BIDI® Sticks, is not legally effective. Accordingly, Kaival Brands plans to market and sell the 11 flavored BIDIs® Sticks, subject to FDA enforcement discretion, while Bidi Vapor is pursuing its lawsuit on the merits challenging the legality of MDO. The FDA has indicated that it is prioritizing enforcement against companies that have not submitted Premarket Tobacco Product Applications (“PMTAs”), or whose PMTAs have been denied acceptance or filed by the FDA, or whose PMTAs remain subject to the MDOs.
After the court granted Bidi Vapor the legal stay of the MDO to February 2022the company sees signs of growing confidence in the vaping industry, with Bidi Vapor’s Electronic Flavored Nicotine Delivery Systems (ENDS) now declared legal for sale pending resolution of the ongoing litigation.
“This was an important event not only for Kaival Brands and Bidi Vapor, but for the entire industry,” Patel said of the court ruling. “The judicial stay granted in February allowed us to resume the sale of all 11 BIDI flavored products® Range of sticks. We look forward to returning our flavored products to the shelves of retailers who comply with the Prevention of All Trafficking in Cigarettes Act so that adult consumers can once again enjoy their favorite flavors. Following the judicial stay, we expect revenue to resume an upward trajectory as renewed distribution ramps up and sales of flavored BIDI® The sticks increase.”
Additionally, we believe that the FDA’s new authority over products using synthetic nicotine will only strengthen Kaival Brands’ position in the market as more and more retailers understand the nearly insurmountable compliance hurdles faced. manufacturers of non-compliant synthetic products. The company applauds recent bipartisan congressional efforts to give the FDA authority over synthetic nicotine. The company, along with Bidi Vapor, prioritizes regulatory compliance to ensure high standards of product quality.
“Vaping industry products must be developed and brought to market under a high degree of oversight, such as the FDA’s PMTA process or the FDA’s drug approval process,” Patel continued. “We anticipate that as the FDA begins to enforce synthetic and illegally marketed nicotine vaping products, there may be increased demand for compliant and legal vaping products, such as BIDI.® To stick on.
Adult smokers aged 21 and over who are looking for an alternative to combustible cigarettes have been our priority from the start,” Patel said. “It hasn’t been an easy road, but we’re fighting to create a level playing field for our products and open a realistic path for adult smokers to change their habits. That is and always has been our commitment.”
ABOUT BIDI STEAM
Situated at Melbourne, FloridaBidi Vapor maintains its commitment to responsible marketing, supporting age verification standards and sustainability through its BIDI® Cares recycling program. Bidi Vapor’s first 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 21+. Bidi Vapor is also adamant about strict adherence to all federal, state, and local guidelines and regulations. At Bidi Vapor, innovation is at the heart of its mission, with the BIDI® Stick promoting environmental sustainability, while providing a unique vaping experience for adult smokers.
For more information visit www.bidivapor.com
ABOUT KAIVAL BRANDS
Situated at Grant, Florida, Kaival Brands 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 in-house develop, acquire, own or exclusively distribute these innovative products and make each market leading brands with superior quality and recognizable innovation. Kaival Brands is the exclusive worldwide distributor of all products manufactured by Bidi Vapor.
Learn more about Kaival Brands Innovations Group, Inc. at https://ir.kaivalbrands.com
This press release contains statements that constitute “forward-looking statements” within the meaning of the federal securities laws, which are statements other than historical facts that frequently use words such as “anticipate”, “believe”, “continue “, “could”, “estimate”, “expect”, “plan”, “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 or implied by the forward-looking statements are reasonable, there can be no assurance that such plans, intentions or expectations will occur. Accordingly, actual results could differ materially from what is expressed, implied or anticipated in such statements. Our business can be influenced by many factors that are difficult to predict, involving uncertainties that could materially affect results and which are often beyond our control. Factors that could cause or contribute to such differences include, but are not limited to, the timing and results of Bidi Vapor’s appeal of FDA PMTA determinations; the scope of future FDA enforcement of regulations in the ENDS industry; the FDA’s approach to regulating synthetic nicotine and its impact on our business; the duration and extent of the COVID-19 pandemic and its impact on demand for the products we distribute; measures taken by governments, businesses and individuals in response to the pandemic, including mandatory business closures and restrictions on on-site business interactions; the impact of the pandemic and measures taken in response to the pandemic on global and regional economies and economic activity; the pace of recovery as the COVID-19 pandemic subsides; general economic uncertainty in major world markets and worsening global economic conditions or low levels of economic growth; the effects of measures we may take to reduce operating costs; our inability to generate and sustain profitable sales growth; circumstances or developments that may prevent us from implementing or realizing the anticipated benefits, or that may increase the costs, of our current and planned business initiatives; changes in government regulations or laws that affect our business; significant changes in our relationship with our distributors or sub-distributors; and the factors detailed by us in our public filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are expressly qualified in their entirety by these cautionary statements. Except as required by federal securities laws and the rules and regulations of the Securities and Exchange Commission, we have no intention or obligation to publicly update any forward-looking statements, whether as a result of new information , future events or otherwise.
SOURCE Kaival Brands