Kaival Brands Innovations Group (KAVL) Announces Judicial Stay of FDA’s Marketing Refusal Order


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Kaival Brands Innovations Group, Inc. (NASDAQ: KAVL), is the exclusive worldwide distributor of products manufactured by Bidi Vapor LLC (“Bidi Vapor”), including the BIDI® Stick Disposable Electronic Nicotine Delivery System (“ENDS”) ), which is intended exclusively for adults 21 and older. The company is pleased to announce that the United States Court of Appeals for the Eleventh Circuit has granted a judicial stay of the marketing denial order (“MDO”) previously issued by the Food and Drug Administration (“FDA “) from the United States to Bidi Vapor in September 2021.

The decision, issued on February 1, 2022, allows Bidi Vapor and Kaival Brands to market and sell all of its BIDI® Stick ENDS, including its tobacco, menthol and flavored products, while Bidi Vapor continues its lawsuit in background forcing the FDA to place Bidi Vapor’s Premarket Tobacco Product Application (“PMTA”) for flavored ENDS is again under scientific review.

With the judicial stay decision in favor of Bidi Vapor, the company expects many distribution partners to restore their previous sales volumes, with potentially new distribution channels added as well.

“We expect this judicial stay to lead to a rebound in sales of BIDI® Stick,” said Niraj Patel, President and CEO of Kaival Brands and Bidi Vapor. “Many wholesale and retail partners had halted or slowed purchases of the BIDI® Stick, until we heard from the courts on the likelihood of our case succeeding on the merits,” Patel said. “This is what our wholesale and retail partners have been waiting for.”

“We believe that Bidi Vapor has developed substantial, robust and reliable scientific evidence through, among other things, surveys, behavioral studies and clinical trials establishing that the product is appropriate for the protection of public health,” Patel said. . “Following the FDA’s initial administrative stay of the MDO, we believe this recent judicial stay is a good indication that the Court finds some merit in Bidi Vapor’s arguments and brings Bidi Vapor’s PMTA closer to a proper evaluation and complete by the FDA. We are extremely pleased with the Court’s decision on this judicial stay order and continue to hope to be successful on the merits as well.”

“The company believes this decision marks another step on the road to providing adult smokers 21 and older with a viable alternative to combustible cigarettes. Distributors, wholesalers, retailers and adult consumers are all eager to see positive results not just for Bidi Vapor, but for the vaping industry as a whole.We believe in science-based regulation of ENDS and hope the courts will require the FDA to adhere to the law when reviewing PMTAs from Bidi Vapor,” Mr. Patel said.

“What gets lost in the public controversy and how the FDA has handled its own marketing approval process is the needs of the adult smoker 21 and older,” Patel said. “The BIDI® Stick may be a viable and effective combustible cigarette option for these adults, and we believe that the data that Bidi Vapor provided to the FDA, such as the recently published PK study, demonstrates this. We look forward to the FDA reviewing all the scientific data submitted by the PMTA and the detailed data that demonstrates that BIDI® Stick is the epitome of compliance and quality. »

Bidi Vapor submitted PMTAs for all 11 flavor varieties (9 flavored ENDS plus menthol and tobacco) of its BIDI® Stick by the court-ordered PMTA deadline of September 9, 2020, despite considerable business and logistical challenges due to the COVID-19 pandemic. The detailed applications were over 285,000 pages long and contained important information supporting the products as appropriate for the protection of public health – including strong and reliable scientific data proving that its flavored BIDI® sticks provide an added benefit to adult smokers. compared to tobacco flavored ENDS. Despite submitting scientifically rigorous PMTAs and keeping the FDA informed of its ongoing clinical and behavioral studies, among others, Bidi Vapor received an MDO for its flavored BIDI® Sticks, as well as almost all other manufacturers of flavored ENDS, in early September 2021. On September 29, 2021, Bidi Vapor filed a petition for review with the United States Court of Appeals for the Eleventh Circuit, seeking judicial review of the MDO under the Act of Tobacco Control (“TCA”), the Administrative Procedure Act (“APA”), and the United States Constitution. Accordingly, Bidi Vapor asked the Court of Appeals to vacate the MDO and provide any further appropriate relief, including the relief necessary to ensure that Bidi Vapor can continue to market the products subject to the MDO to its adult customers. The court-ordered stay issued on February 1, 2022 allows Bidi Vapor to continue to market all of its products in the United States, pending the outcome of the trial.

Bidi Vapor remains committed to regulatory compliance and the pre-market review process and is moving forward with its planned studies to support its PMTAs. Behavioral studies of Bidi Vapor show that the majority of BIDI® Stick users are older smokers who have either successfully quit smoking completely or have been able to significantly reduce the number of cigarettes smoked daily. This aligns with the completed clinical pharmacokinetic (PK) study of Bidi Vapor, which demonstrates that BIDI® sticks deliver nicotine to adult consumers in a comparable manner to their usual cigarette brand and also caused similar subjective effects. In short, behavioral studies and the PK study demonstrate that BIDI® sticks can be a satisfactory alternative to cigarettes for current smokers and can help them quit smoking.

Mr. Patel, Chairman and CEO of the company, owns and controls Bidi Vapor. Accordingly, Bidi Vapor and the Company are considered to be under common control and Bidi Vapor is considered a related party.

ABOUT BIDI STEAM

Based in Melbourne, Florida, Bidi 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 and older. Bidi Vapor is also adamant about strict adherence to all federal, state, and local guidelines and regulations. At Bidi Vapor, innovation is key to our mission, with the BIDI® Stick promoting environmental sustainability, while providing a unique vaping experience for adult smokers.

ABOUT KAIVAL BRANDS

Based in Grant, Florida, Kaival Brands Innovations Group 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 www.ir.kaivalbrands.com.

Forward-looking statements

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 successful implementation of the Bidi® Stick Company’s distribution expansion into international markets, the duration and extent of the COVID-19 pandemic and the 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.

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SOURCE Kaival Brands

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