FDA Enters Administrative Stay of Bidi Vapor's Marketing Denial Order for its Flavored ENDS

GRANT, Fla., Oct. 27, 2021 /PRNewswire/ -- Kaival Brands Innovations Group, Inc. (NASDAQ: KAVL) ("Kaival Brands," the "Company," or "we"), is the exclusive global 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 over. Bidi Vapor LLC, the manufacturer of the premium BIDI^® Stick electronic nicotine delivery system (ENDS), announced today that on Friday, October 22, 2021, FDA issued an administrative stay, pursuant to 21 C.F.R. § 10.35, of its Marketing Denial Order (MDO) for its non-tobacco flavored BIDI^® Sticks, pending the Agency's review of the Company's request that the MDO be rescinded based on product-specific scientific evidence in its Premarket Tobacco Product Applications (PMTAs). FDA confirmed that while it reviews Bidi Vapor's request, its flavored BIDI^® Sticks can remain on the market without the threat of enforcement.

Prior to the court-ordered September 9, 2020, PMTA deadline and despite considerable business and logistical challenges due to the COVID-19 pandemic, Bidi Vapor submitted PMTAs for all 11 flavor varieties of its BIDI^® Stick, which is intended exclusively for adult cigarette smokers and tobacco users, 21 and over. The detailed applications ran over 285,000 pages and contained significant information supporting the products as appropriate for the protection of the public health (APPH). Despite submitting scientifically rigorous PMTAs and keeping FDA informed about its ongoing clinical and behavioral studies, Bidi Vapor received an MDO for its flavored BIDI^® Sticks, along with nearly all other manufacturers of flavored ENDS, in early September 2021.

On September 29, 2021, Bidi Vapor filed a Petition for Review with the U.S. Court of Appeals for the Eleventh Circuit, seeking judicial review of the MDO under the Tobacco Control Act (TCA), the Administrative Procedure Act (APA), as well as the U.S. Constitution. Accordingly, Bidi Vapor has requested the appellate court to vacate the MDO, and provide such additional relief as may be appropriate, including such relief as necessary to ensure that Bidi may continue to market the products subject to the MDO to its adult customers.

"We appreciate FDA's decision to stay, or put on hold, the MDO as it reconsiders its denial. As we explained to the Agency, Bidi Vapor submitted scientifically rigorous PMTAs that contained product-specific evidence demonstrating that the added benefit of our flavored BIDI^® Sticks to adult smokers outweighs any potential risks to youth, especially considering our stringent youth-access prevention measures and commitment to mature, adult-focused marketing," said Niraj Patel, the Company's CEO.

"That said, we are still seeking a formal, judicial stay from the appellate court pending the outcome of the lawsuit," Patel noted. 

The Company has now filed a Motion for Stay Pending Review with the 11th Circuit Court of Appeals because of the continued irreparable harm the MDO has caused. The stay motion summarizes how FDA's actions were unlawful, as it was arbitrary and capricious, as well as ultra vires, for FDA not to conduct any scientific review of the PMTAs. FDA also violated due process and the APA by failing to provide fair notice of the apparent requirement for a specific-type of long-term study, which it had previously indicated would not be required. 

Regarding the litigation, Patel noted, "We believe in science-based regulation of ENDS and hope the courts will require FDA to adhere to the law as it reviews our PMTAs."

Bidi Vapor remains committed to regulatory compliance and the premarket review process and is forging ahead with its planned studies to support its PMTAs. The Company's behavioral studies show that the majority of BIDI^® Stick consumers are older smokers who were either able to transition completing away from smoking or were able to significantly reduce the number of daily cigarettes smoked. This corresponds with the Bidi Vapor's completed clinical pharmacokinetic (PK) study, which will soon be published, which demonstrates that the BIDI^® Sticks deliver nicotine to adult consumers comparable to their usual cigarette brand and also elicited similar subjective effects. In short, the behavioral studies and PK study demonstrate that the BIDI^® Sticks may be a satisfying alternative to cigarettes among current smokers and may support their transitioning away from cigarette smoking.

"These study results are exciting, but we are continuing to develop product-specific data to support the marketing of the BIDI^® Stick for adult smokers. A tough road lies ahead, but we look forward to the challenge and working with FDA to secure marketing authorization for our products," Patel said.

ABOUT BIDI VAPOR
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 for adults 21 and over. Bidi Vapor is also adamant about strict compliance with 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 to adult smokers.

For more information, visit www.bidivapor.com

ABOUT KAIVAL BRANDS
Based in 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 develop internally, acquire, own, or exclusively distribute these innovative products and grow each into dominant market-share brands with superior quality and recognizable innovation. Kaival Brands is the exclusive global 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 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. Our business may be influenced by many factors that are difficult to predict, involve uncertainties that may materially affect results, and 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 the FDA's PMTA process; the scope of future FDA enforcement of regulations in the ENDS industry; the FDA's approach to the regulation of synthetic nicotine and its impact on our business; the duration and scope of the COVID-19 pandemic and impact on the demand for the products we distribute; the actions governments, businesses, and individuals take in response to the pandemic, including mandatory business closures and restrictions on onsite commercial interactions; the impact of the pandemic and actions taken in response to the pandemic on global and regional economies and economic activity; the pace of recovery when the COVID-19 pandemic subsides; general economic uncertainty in key global markets and a worsening of global economic conditions or low levels of economic growth; the effects of steps that we could take to reduce operating costs; our inability to generate and sustain profitable sales growth; circumstances or developments that may make us unable to implement or realize anticipated benefits, or that may increase the costs, of our current and planned business initiatives; changes in government regulation or laws that affect our business; significant changes in our relationships with our distributors or sub-distributors; and those 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 such cautionary statements. Except as required under the federal securities laws and the Securities and Exchange Commission's rules and regulations, we do not have any intention or obligation to update any forward-looking statements publicly, whether as a result of new information, future events, or otherwise.

SOURCE Kaival Brands

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