Kaival Brands Innovations Group Inc. (NASDAQ: KAVL
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Posted On: 02/09/2022 3:03:32 PM
Kaival Brands Innovations Group Inc. (NASDAQ: KAVL) Win Judicial Stay of the FDA’s Marketing Denial Order
- Kaival Brands is the exclusive global distributor of products manufactured by Bidi Vapor LLC
- Bidi Vapor announced that it has been granted a judicial stay of the marketing denial order issued by the FCA in September 2021, which will permit the company to market all its products in the United States, pending the outcome of the lawsuit
- Kaival Brands expect the decision to result in a significant rebound in BIDI(R) Stick sales, with the company’s distribution partners expected to reestablish previous sales volumes
Kaival Brands Innovations Group (NASDAQ: KAVL), the exclusive global distributor of products manufactured by Bidi Vapor LLC (“Bidi Vapor”), including the BIDI(R) Stick disposable electronic nicotine delivery system (“ENDS”), which is intended exclusively for adults 21 and over, announced, that the U.S. Court of Appeals for the Eleventh Circuit has granted a judicial stay of the marketing denial order (“MDO”) previously issued by the U.S. Food and Drug Administration (“FDA”) to Bidi Vapor in September 2021. The stay order, which was issued on February 1, 2022, allows Bidi Vapor and Kaival Brands to market and sell all of its BIDI(R) Stick ENDS, including its tobacco, menthol, and flavored products within the United States pending the outcome of the lawsuit; moreover, Bidi Vapor has also reiterated its intention to continue with its merits lawsuit which is set to compel the FDA to place Bidi Vapor’s Premarket Tobacco Product Application (‘PMTA’) for the favored ENDS back under scientific review.
Bidi Vapor had previously submitted PMTAs for all 11 of their flavor varieties (9 flavored ENDS offerings in addition to Menthol and Tobacco) of its BIDI(R) Stick prior to the original September 9, 2020 PMTA deadline, with the detailed applications running to over 285,000 pages – including robust and reliable scientific data supporting that its flavored BIDI(R) Sticks provide an added benefit to adult smokers over tobacco-flavored ENDS. Nonetheless, the regulatory overview of the United States’ vape market remains largely a work in progress, with the FDA’s decision last September to take more time to process outstanding PMTA’s leading to a temporary removal of over 946 thousand flavored e-cigarette products from the US marketplace (https://nnw.fm/bRpVt).
Kaival Brands have placed strict focus on their regulatory compliance from both, a manufacturing and retailing standpoint, with recent behavioral studies carried out by the company revealing that the majority of BIDI(R) Stick consumers were older smokers who were either able to transition completely away from smoking or were able to significantly reduce the number of daily cigarettes smoked. The company’s proactive and compliant stance has been reflected by the recent favorable judicial stay decision, which permits Bidi Vapor to resume marketing on all products in the United States, pending the outcome of the lawsuit.
“We expect this judicial stay will result in a rebounding of BIDI(R) Stick sales,” said Niraj Patel, president and CEO of both Kaival Brands and Bidi Vapor. “Many wholesale and retail partners had discontinued or slowed purchases of the BIDI(R) Stick, until we heard back from the courts on the likelihood of our merits case succeeding,” Patel said. “This is what our wholesale and retail partners have been waiting for.”
Patel further elaborated on the company’s compliances with FDA norms, as well as Bidi Vapor and Kaival Brands’ goal of providing adult smokers, 21 and older, with a viable alternative to combustible cigarettes.
“We believe that Bidi Vapor has developed substantial, robust and reliable scientific evidence through, among other things, surveys, behavioral studies and clinical trials establishing support that the product is appropriate for the protection of the public health,” Patel said. “Following on FDA’s initial administrative stay of the MDO, we believe that this recent judicial stay is a good indication that the Court finds some merit in Bidi Vapor’s arguments and puts Bidi Vapor’s PMTA one step closer to being properly and fully evaluated by FDA”.
For more information, visit the company’s website at www.KaivalBrands.com.
NOTE TO INVESTORS: The latest news and updates relating to KAVL are available in the company’s newsroom at http://nnw.fm/KAVL
Please see full disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
- Kaival Brands is the exclusive global distributor of products manufactured by Bidi Vapor LLC
- Bidi Vapor announced that it has been granted a judicial stay of the marketing denial order issued by the FCA in September 2021, which will permit the company to market all its products in the United States, pending the outcome of the lawsuit
- Kaival Brands expect the decision to result in a significant rebound in BIDI(R) Stick sales, with the company’s distribution partners expected to reestablish previous sales volumes
Kaival Brands Innovations Group (NASDAQ: KAVL), the exclusive global distributor of products manufactured by Bidi Vapor LLC (“Bidi Vapor”), including the BIDI(R) Stick disposable electronic nicotine delivery system (“ENDS”), which is intended exclusively for adults 21 and over, announced, that the U.S. Court of Appeals for the Eleventh Circuit has granted a judicial stay of the marketing denial order (“MDO”) previously issued by the U.S. Food and Drug Administration (“FDA”) to Bidi Vapor in September 2021. The stay order, which was issued on February 1, 2022, allows Bidi Vapor and Kaival Brands to market and sell all of its BIDI(R) Stick ENDS, including its tobacco, menthol, and flavored products within the United States pending the outcome of the lawsuit; moreover, Bidi Vapor has also reiterated its intention to continue with its merits lawsuit which is set to compel the FDA to place Bidi Vapor’s Premarket Tobacco Product Application (‘PMTA’) for the favored ENDS back under scientific review.
Bidi Vapor had previously submitted PMTAs for all 11 of their flavor varieties (9 flavored ENDS offerings in addition to Menthol and Tobacco) of its BIDI(R) Stick prior to the original September 9, 2020 PMTA deadline, with the detailed applications running to over 285,000 pages – including robust and reliable scientific data supporting that its flavored BIDI(R) Sticks provide an added benefit to adult smokers over tobacco-flavored ENDS. Nonetheless, the regulatory overview of the United States’ vape market remains largely a work in progress, with the FDA’s decision last September to take more time to process outstanding PMTA’s leading to a temporary removal of over 946 thousand flavored e-cigarette products from the US marketplace (https://nnw.fm/bRpVt).
Kaival Brands have placed strict focus on their regulatory compliance from both, a manufacturing and retailing standpoint, with recent behavioral studies carried out by the company revealing that the majority of BIDI(R) Stick consumers were older smokers who were either able to transition completely away from smoking or were able to significantly reduce the number of daily cigarettes smoked. The company’s proactive and compliant stance has been reflected by the recent favorable judicial stay decision, which permits Bidi Vapor to resume marketing on all products in the United States, pending the outcome of the lawsuit.
“We expect this judicial stay will result in a rebounding of BIDI(R) Stick sales,” said Niraj Patel, president and CEO of both Kaival Brands and Bidi Vapor. “Many wholesale and retail partners had discontinued or slowed purchases of the BIDI(R) Stick, until we heard back from the courts on the likelihood of our merits case succeeding,” Patel said. “This is what our wholesale and retail partners have been waiting for.”
Patel further elaborated on the company’s compliances with FDA norms, as well as Bidi Vapor and Kaival Brands’ goal of providing adult smokers, 21 and older, with a viable alternative to combustible cigarettes.
“We believe that Bidi Vapor has developed substantial, robust and reliable scientific evidence through, among other things, surveys, behavioral studies and clinical trials establishing support that the product is appropriate for the protection of the public health,” Patel said. “Following on FDA’s initial administrative stay of the MDO, we believe that this recent judicial stay is a good indication that the Court finds some merit in Bidi Vapor’s arguments and puts Bidi Vapor’s PMTA one step closer to being properly and fully evaluated by FDA”.
For more information, visit the company’s website at www.KaivalBrands.com.
NOTE TO INVESTORS: The latest news and updates relating to KAVL are available in the company’s newsroom at http://nnw.fm/KAVL
Please see full disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
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