Vaping Industry Reacts as FDA Deadline on Synthetic Nicotine Arrives

Kaival Brands supports enforcement of new prohibition on ENDS that use non-tobacco derived or synthetic nicotine

GRANT, Fla., July 14, 2022 /PRNewswire/ -- Kaival Brands Innovations Group, Inc. (NASDAQ: KAVL) ("Kaival Brands," the "Company," or "we"), the U.S. distributor of all products manufactured by Bidi Vapor, LLC ("Bidi Vapor"), which are intended for legal-age nicotine users, today announced its support of statements from Bidi Vapor, regarding its continuing support of the U.S. Food and Drug Administration (FDA)'s authority over electronic nicotine delivery systems (ENDS) devices using non-tobacco derived or "synthetic" nicotine. With the arrival of a major deadline on July 13, 2022 that will make the continued retail and distribution of all such products illegal, the Company hopes the FDA will use its powers to properly enforce its new policies. Bidi Vapor does not use synthetic nicotine in any product.

After July 13th, all synthetic nicotine products on the market will be in violation of the agency's new statutes and will be subject to FDA enforcement, unless they receive a marketing authorization from the FDA by July 13, 2022?a virtual impossibility, said officials with Bidi Vapor, based in Melbourne, Florida. 

Retailers who keep these products on their store shelves could also face enforcement and penalties for selling "adulterated" tobacco products, according to the FDA guidelines.

"Now, with this new authority given to the FDA, all products containing nicotine from any source will have to undergo the same rigorous authorization process to legally go to market here in the United States," said Niraj Patel, Chief Science and Regulatory Officer of Kaival Brands. "More importantly, it focuses manufacturers who use synthetic nicotine to align with the FDA's priority of making these types of adult consumer products appropriate for the protection of the public health."

Patel cautioned retailers who continue to sell devices with synthetic nicotine after July 13th. "C-store retailers should pay close attention to what products are permitted for sale and are compliant with the requirements of the FDA, the Prevent All Cigarette Trafficking or PACT Act, and numerous state and local licensing and tax laws," Patel said. "We anticipate that as the FDA begins enforcement against illegally marketed and synthetic-nicotine vaping products, there may be an increased demand for the few remaining ENDS products made with tobacco-derived nicotine that are not currently subject to marketing denial orders, such as the BIDI^® Stick."

Bidi Vapor announced its official position on synthetic nicotine in the Company's financial report published on September 14, 2021. It also shared its opinion directly with members of Congress and FDA leadership, most recently in letters to Dr. Robert Califf, the FDA commissioner, as well as Dr. Brian King, the new Director of FDA's Center for Tobacco Products.

"We hope retailers take a serious look at who their partners are," Patel said. "You want to partner with companies that comply with regulations and produce high-quality products. That's the only way the industry will survive and thrive in the future, prevent youth-access, and continue to offer adult smokers alternatives to combustible cigarettes."

Mr. Patel, the Company's Chief Science and Regulatory Officer, owns and controls Bidi Vapor. As a result, Bidi Vapor and the Company are considered under common control and Bidi Vapor is considered a related party.

ABOUT BIDI VAPOR

Based in Melbourne, Florida, Bidi Vapor maintains a commitment to responsible adult-focused marketing, strict youth access prevention measures and age-verification standards, as well as sustainability through its BIDI^® Cares recycling program. Bidi Vapor's device, the BIDI^® Stick, is a premium product made with high-quality components, a UL-certified battery and technology designed to deliver a consistent vaping experience for adult smokers 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 its 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 rands Innovations Group, Inc., 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 and Philip Morris International Inc. are the exclusive global distributors of products manufactured by Bidi Vapor.

Learn more about Kaival Brands 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 success of our agreement with PMI, how quickly international markets adopt our product, the timing and results of Bidi Vapor's appeal of the FDA's PMTA denials for its non-tobacco flavored ENDS products; 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; potential federal and state flavor bans and other restrictions on ENDS products; 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, including sales growth in the international markets; 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