NetworkNewsBreaks – Kaival Brands Innovations Gr
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Posted On: 10/27/2021 3:02:28 PM
NetworkNewsBreaks – Kaival Brands Innovations Group Inc. (NASDAQ: KAVL) Announces Legal Efforts to Change MDO Stay on Bidi Sticks
Kaival Brands (NASDAQ: KAVL), the exclusive global distributor of products by Bidi(R) Vapor LLC, has shared efforts being made to change a previously announced administrative stay on Bidi(R) Sticks. KAVL noted that Bidi Vapor LLC, the manufacturer of the premium Bidi Stick electronic nicotine delivery system (“ENDS”) has asked the FDA to reconsider its marketing denial order (“MDO”) for the Bidi Sticks. The company made this request based on the scientific evidence in its applications. Bidi Vapor is also requesting a judicial stay of the MDO with the 11th Circuit Court of Appeals. According to the announcement, the FDA issued an administrative stay of the MDO for the nontobacco-flavored BIDI Sticks pending its review of the company’s request that the MDO be rescinded. While it reviews the request, the FDA confirmed that Bidi Vapor’s flavored BIDI Sticks can remain on the market. In further action, last month Bidi Vapor filed a petition for review with the U.S. Court of Appeals for the Eleventh Circuit, asking the court to review the MDO under the Tobacco Control Act (“TCA”), the Administrative Procedure Act (“APA”) and the U.S. Constitution. The filing also includes a request to vacate the MDO and provide additional relief. “We appreciate FDA’s decision to stay, or put on hold, the MDO as it reconsiders its denial,” said Kaival Brands CEO Niraj Patel in the press release. “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. . . . That said, we are still seeking a formal, judicial stay from the appellate court pending the outcome of the lawsuit. 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.”
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 (NASDAQ: KAVL), the exclusive global distributor of products by Bidi(R) Vapor LLC, has shared efforts being made to change a previously announced administrative stay on Bidi(R) Sticks. KAVL noted that Bidi Vapor LLC, the manufacturer of the premium Bidi Stick electronic nicotine delivery system (“ENDS”) has asked the FDA to reconsider its marketing denial order (“MDO”) for the Bidi Sticks. The company made this request based on the scientific evidence in its applications. Bidi Vapor is also requesting a judicial stay of the MDO with the 11th Circuit Court of Appeals. According to the announcement, the FDA issued an administrative stay of the MDO for the nontobacco-flavored BIDI Sticks pending its review of the company’s request that the MDO be rescinded. While it reviews the request, the FDA confirmed that Bidi Vapor’s flavored BIDI Sticks can remain on the market. In further action, last month Bidi Vapor filed a petition for review with the U.S. Court of Appeals for the Eleventh Circuit, asking the court to review the MDO under the Tobacco Control Act (“TCA”), the Administrative Procedure Act (“APA”) and the U.S. Constitution. The filing also includes a request to vacate the MDO and provide additional relief. “We appreciate FDA’s decision to stay, or put on hold, the MDO as it reconsiders its denial,” said Kaival Brands CEO Niraj Patel in the press release. “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. . . . That said, we are still seeking a formal, judicial stay from the appellate court pending the outcome of the lawsuit. 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.”
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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