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stay of the MDO for the nontobacco-flavored BIDI Sticks pending its review of the company’s request that the MDO be rescinded.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.”
To view the full press release, visit https://ibn.fm/79ltD
About Kaival Brands Innovations Group Inc.
Based in Grant, Florida, Kaival Brands is a company focused on growing and incubating innovative and profitable products into mature and dominant brands in their respective markets. The company’s 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 is the exclusive global distributor of all products manufactured by Bidi Vapor. For more information about the company, visit www.KaivalBrands.com.
NOTE TO INVESTORS: The latest news and updates relating to KAVL are available in the company’s newsroom at http://ibn.fm/KAVL
InvestorWire is the wire service that gives you more. From regional releases to global announcements presented in multiple languages, we offer the wire-grade dissemination products you’ll need to ensure that your next press release grabs the attention of your target audience and doesn’t let go. While our competitors look to nickel and dime you with hidden fees and restrictive word limits, InvestorWire keeps things transparent. We offer UNLIMITED Words on all domestic releases. While other wire services may provide a basic review of your release, InvestorWire helps you put your best foot forward with complimentary Press Release Enhancement.
With our competitors, the work is done the second your release crosses the wire. Not with InvestorWire. We include follow-up coverage of every release by leveraging the ever-expanding audiences of the 50+ brands that make up the InvestorBrandNetwork.
Get more out of your next press release with InvestorWire. It’s unlike anything you’ve seen before.
For more information, please visit https://www.investorwire.com
InvestorWire is part of the InvestorBrandNetwork.