Kaival Brands Innovations Group, Inc. (NASDAQ:
KAVL) ("Kaival Brands," the "Company" or "we,” “our” or
similar terms), the exclusive distributor of all products
manufactured by Bidi Vapor, LLC (“Bidi Vapor”), including the BIDI®
Stick electronic nicotine delivery system (ENDS), which are
intended for adults 21 and over, today provided an update on the
evolving regulatory landscape of the e-cigarette and vaping
industry. As the exclusive U.S. distributor of products
manufactured by Bidi Vapor, LLC, which are fully compliant with all
current FDA regulations, Kaival Brands is positioned at the
forefront of the market as the FDA intensifies its enforcement
actions against non-compliant and illicit e-cigarette products.
Recent reports have highlighted a significant
increase in the FDA's enforcement activities, targeting
unauthorized vape products that have flooded the market. The FDA's
efforts have become more strategic and impactful, with a focus on
intercepting illegal imports and issuing fines and injunctions
against violators. This crackdown is expected to reshape the
competitive landscape, particularly within large regional and
national retailers, where compliance with federal regulations is
paramount.
In light of the U.S. International Trade
Commission's (ITC) ongoing efforts to address unfair imports and
sales practices in the vaping sector, Kaival Brands underscores the
importance of such regulatory actions in maintaining a fair and
lawful marketplace. The ITC's role in investigating and potentially
issuing exclusion and cease and desist orders against illicit
imports is a critical component in the fight against the
unauthorized e-cigarette market.
Kaival Brands commends both the ITC’s and the
FDA's commitment to enforcing the law and protecting public health.
The Company's partnership with Bidi Vapor ensures that its
offerings, including the BIDI® Stick, are not only compliant with
all FDA regulations but also do not contribute to the youth vaping
epidemic. Bidi Vapor's stringent marketing and age-verification
practices demonstrate an industry-leading stance on responsible
consumption.
"As the FDA continues to clear the market of
illicit and non-compliant e-cigarette products, Kaival Brands
stands ready to meet the demand for legal and regulated
alternatives," said Eric Mosser, President and CEO of Kaival
Brands. "Our commitment to compliance and excellence positions us
to capture a significant market share as the FDA's enforcement
actions take effect."
The FDA's recent actions, including fines and
the seizure of unauthorized products, signal a new era of rigorous
enforcement. Kaival Brands anticipates that these measures will
lead to a substantial reduction in the availability of illicit vape
products, particularly in outlets that prioritize regulatory
compliance.
Kaival Brands is dedicated to maintaining the
highest standards of product integrity and regulatory adherence.
The Company's proactive approach to compliance ensures that its
products, including those manufactured by Bidi Vapor, will remain
on shelves while non-compliant products are removed. This
commitment not only supports public health initiatives but also
provides a competitive advantage in the marketplace.
As the FDA finalizes its review of premarket
tobacco product applications (PMTAs), including those submitted by
Bidi Vapor, Kaival Brands is optimistic about the future. The
Company believes that its adherence to regulatory requirements and
its commitment to high-quality, compliant products will drive
growth and profitability in an increasingly regulated market.
For more information about Kaival Brands and its
commitment to compliance and quality, please visit Kaival Brands'
website: https://ir.kaivalbrands.com
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 (known as 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.
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,” “prospects,” “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 will be able to monetize the acquired assets
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 and our ability to expand and grow our business due to the
assets we acquired from GoFire may be influenced by many factors
that are difficult to predict, involve significant risks and
uncertainties that may materially affect actual 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 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 or other sectors we may enter, including the
cannabis industry, (vi) the FDA’s approach to the regulation of
synthetic nicotine and other potential products we may manufacture
or sell in the future and its impact on our business, (vii)
potential federal and state flavor or other bans and other
restrictions on ENDS products and other potential products we may
manufacture or sell in the future, (viii) whether we will be able
to successfully integrate and capitalize on the patents we have
acquired from GoFire, of which no assurances can be given, (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.
Investor Relations:Brett Maas, Managing
PartnerHayden IR(646)
536-7331IR.kaivalbrands.combrett@haydenir.com
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