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
EnforcementIn 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”
1 https://www.fda.gov/news-events/press-announcements/fda-conducts-retailer-inspection-blitz-cracks-down-illegal-sales-popular-disposable-e-cigarettes2
https://www.fda.gov/news-events/press-announcements/fda-inspection-blitz-leads-more-180-warning-letters-retailers-illegal-sale-youth-appealing-elf-bar
ABOUT KAIVAL BRANDS
Based in Grant-Valkaria, Florida, Kaival Brands
is a company focused on incubating innovative and profitable
adult-focused products into mature and dominant brands, with a
current focus on the distribution of electronic nicotine delivery
systems (“ENDS”) also known as “e-cigarettes”. Our business plan is
to seek to diversify into distributing other nicotine and
non-nicotine delivery system products (including those related to
hemp-derived cannabidiol (“CBD”) products). Kaival Brands and
Philip Morris Products S.A. (via sublicense from Kaival Brands) are
the exclusive global distributors of all products manufactured by
Bidi Vapor.
Learn more about Kaival Brands at
https://ir.kaivalbrands.com/overview/default.aspx.
ABOUT KAIVAL LABS
Based in Grant-Valkaria, Florida, Kaival Labs is
a 100% wholly-owned subsidiary of Kaival Brands focused on
developing new branded and white-label products and services in the
vaporizer and inhalation technology sectors. Kaival Labs’ current
patent portfolio consists of 12 existing and 46 pending with novel
technologies across extrusion dose control, product preservation,
tracking and tracing usage, multiple modalities and child safety.
The patents and patent applications cover territories including the
United States, Australia, Canada, China, the European Patent
Organisation, Israel, Japan, Mexico, New Zealand and South Korea.
The portfolio also includes a fully-functional proprietary mobile
device software application that is used in conjunction with
certain patents in the portfolio.
Learn more about Kaival Labs at
https://kaivallabs.com.
ABOUT BIDI VAPOR
Based in Melbourne, Florida, Bidi Vapor
maintains a commitment to responsible, adult-focused marketing,
supporting age-verification standards and sustainability through
its BIDI® Cares recycling program. Bidi Vapor's premier device, the
BIDI® Stick, is a premium product made with high-quality
components, a UL-certified battery and technology designed to
deliver a consistent vaping experience for adult smokers 21 and
over. Bidi Vapor is also adamant about strict compliance with all
federal, state and local guidelines and regulations. At Bidi Vapor,
innovation is key to its mission, with the BIDI® Stick promoting
environmental sustainability, while providing a unique vaping
experience to adult smokers.
Nirajkumar Patel, the Company’s Chief Science
and Regulatory Officer and director, owns and controls Bidi Vapor.
As a result, Bidi Vapor is considered a related party of the
Company.
For more information, visit
www.bidivapor.com.
Cautionary Note Regarding
Forward-Looking Statements
This press release and the statements of the
Company’s management and partners included herein and related to
the subject matter herein includes statements that constitute
“forward-looking statements” (as defined in Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended), which are statements
other than historical facts. You can identify forward-looking
statements by words such as “anticipate,” “believe,” “continue,”
“could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,”
“position,” “should,” “strategy,” “target,” “will,” and similar
words. All forward-looking statements speak only as of the date of
this press release. Although we believe that the plans, intentions,
and expectations reflected in or suggested by the forward-looking
statements are reasonable, there is no assurance that these plans,
intentions, or expectations will be achieved. Therefore, actual
outcomes and results (including, without limitation, the results of
the Company’s sales and marketing efforts as described herein and
the impact of such efforts on the Company’s results of operations)
could materially and adversely differ from what is expressed,
implied, or forecasted in such statements. Our business may be
influenced by many factors that are difficult to predict, involve
uncertainties that may materially affect results, and are often
beyond our control. Factors that could cause or contribute to such
differences include, but are not limited to: (i) future actions by
the FDA in response to the 11th Circuit Court’s decision that could
impact our business and prospects, (ii) the outcome of FDA’s
scientific review of Bidi Vapor’s pending FDA Premarket Tobacco
Product Applications, (iii) the results of international marketing
and sales efforts by Philip Morris International, the Company’s
international distribution partner, (iv) how quickly domestic and
international markets adopt our products, (v) the scope of future
FDA enforcement of regulations in the ENDS industry, (vi) the FDA’s
approach to the regulation of synthetic nicotine and its impact on
our business, (vii) potential federal and state flavor bans and
other restrictions on ENDS products, (viii) the duration and scope
of the COVID-19 pandemic and impact on the demand for the products
we distribute, (ix) general economic uncertainty in key global
markets and a worsening of global economic conditions or low levels
of economic growth, (x) the effects of steps that we could take to
reduce operating costs, (xi) our inability to generate and sustain
profitable sales growth, including sales growth in U.S. and
international markets, (xii) circumstances or developments that may
make us unable to implement or realize anticipated benefits, or
that may increase the costs, of our current and planned business
initiatives, (xiii) significant changes in our relationships with
our distributors or sub-distributors and (xiv) other factors
detailed by us in our public filings with the Securities and
Exchange Commission, including the disclosures under the heading
“Risk Factors” in our Annual Report on Form 10-K for the fiscal
year ended October 31, 2022, filed with the Securities and Exchange
Commission on January 27, 2023 and accessible at www.sec.gov.
All forward-looking statements included in this press release are
expressly qualified in their entirety by such cautionary
statements. Except as required under the federal securities laws
and the Securities and Exchange Commission’s rules and regulations,
we do not have any intention or obligation to update any
forward-looking statements publicly, whether as a result of new
information, future events, or otherwise.
Kaival Brands Investor Relations:Brett Maas,
Managing PartnerHayden IR(646) 536-7331brett@haydenir.com
Kaival Brands Innovations (NASDAQ:KAVL)
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Kaival Brands Innovations (NASDAQ:KAVL)
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