Kaival Brands Innovations Group Inc (KAVL)

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$KAVL Vaping Industry Reacts as FDA Deadline on Synthetic Nicotine Arrives

https://www.prnewswire.com/news-releases/vaping-industry-reacts-as-fda-deadline-on-synthetic-nicotine-arrives-301586691.html

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.