$KAVL Kaival Brands Commends Recent FDA Regulation

$KAVL Kaival Brands Commends Recent FDA Regulation Efforts

https://www.globenewswire.com/news-release/20...forts.html

GRANT-VALKARIA, Fla., Aug. 30, 2023 (GLOBE NEWSWIRE) -- Kaival Brands Innovations Group, Inc. (NASDAQ: KAVL) ("Kaival Brands," the "Company," or "we" , the exclusive U.S. distributor of all products manufactured by Bidi Vapor, LLC ("Bidi Vapor" , which are intended for adults 21 and over, today provided an update on the efforts by the U.S. Food and Drug Administration (“FDA”) to address youth-access prevention, illegitimate, illicit products in the marketplace, and an update on recent announcements by the FDA regarding completion of certain Premarket Tobacco Product Applications (“PMTAs”) by December 2023.

Eric Mosser, Chief Executive Officer of Kaival Brands, stated, “We commend the recent enforcement efforts of the FDA to address the problem of illicit and illegal vaping products in the market right now. Most of the items you see on the shelf in your local store are illegal as per the PMTA guidelines, and we anticipate it is simply a matter of time before the market is finally cleared of those illicit vaping products, leaving only compliant and authorized products available in the market to buy, such as the Bidi Vapor product line as anticipated by the Company.”

Completed FDA Reviews of Market Dominant PMTAs Expected by December 2023

The FDA has recently provided a timeline on anticipated reviews of certain “covered” PMTAs to be completed. Covered PMTAs are limited only to applications: 1) for new tobacco products that were on the market by Aug. 8, 2016; 2) that were timely-submitted by the Sept. 9, 2020 court-established deadline; and 3) for products sold under the brand names Vuse, Juul, NJOY, Logic, SMOK, Blu, Puff Bar or Suorin, or that reach 2% of total retail dollar sales as reported in the Total E-Cig Market and Players report or the Disposable E-Cig Market and Players report, as produced by Chicago-based NielsenIQ.

BIDI® Stick: 1) was on the market prior to August 8, 2016; 2) are subject to PMTAs that were timely submitted by the September 9, 2020 deadline, and have now entered scientific review; and 3) has consistently been the number one disposable vape product for more than twenty-four months since 2021 and has consistently reached 2% of total retail dollar sales as reported in the Total E-Cig Market and Players report or the Disposable E-Cig Market and Players report, as produced by Chicago-based NielsenIQ.

The FDA anticipates action on:

52% of covered PMTAs by March 31;
53% of covered PMTAs by June 30;
55% of covered PMTAs by Sept. 30;
100% of covered PMTAs by Dec. 31.

Capitalizing on the Tailwinds of Increased FDA Enforcement
In May 2023, the FDA launched a self-proclaimed “Inspection Blitz,” which underscores the agency’s unwavering commitment to addressing the issue facing America’s youth.1

Both the Company and Bidi Vapor have remained steadfastly committed to compliance and youth-access prevention. That commitment, along with the renewed focus and commitment by retailers, will continue to help educate consumers and raise awareness about the importance of youth access prevention and buying legitimate, non-illicit products. As reiterated by Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products (CTP), “all players in the supply chain—including retailers—have a role in keeping illegal e-cigarettes off the shelves. 2”