$KAVL FDA Enters Administrative Stay of Bidi Vapor's Marketing Denial Order for its Flavored ENDS
https://finance.yahoo.com/news/fda-enters-adm...00554.html
Manufacturer of the premium BIDI® Stick ENDS has requested FDA reconsider its MDO based on the scientific evidence in its applications, while also seeking a judicial stay of the MDO with the 11th Circuit Court of Appeals
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(MDO) for its non-tobacco flavored BIDI® Sticks, pending the Agency's review of the Company's request that the MDO be rescinded based on product-specific scientific evidence in its Premarket Tobacco Product Applications (PMTAs).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.
FDA Enters Administrative Stay of Bidi Vapor's Marketing Denial Order for its Flavored ENDS
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.
https://finance.yahoo.com/news/fda-enters-adm...00554.html
Manufacturer of the premium BIDI® Stick ENDS has requested FDA reconsider its MDO based on the scientific evidence in its applications, while also seeking a judicial stay of the MDO with the 11th Circuit Court of Appeals
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. FDA Enters Administrative Stay of Bidi Vapor's Marketing Denial Order for its Flavored ENDS
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.
