GRANT, Fla., Oct. 27, 2021 /PRNewswire/ -- Kaival Brands
Innovations Group, Inc. (NASDAQ: KAVL) ("Kaival Brands," the
"Company," or "we"), is the exclusive global distributor of
products manufactured by Bidi Vapor, LLC ("Bidi Vapor"), including
the BIDI® Stick
disposable electronic nicotine delivery system ("ENDS"), which
is intended exclusively for adults 21 and over. Bidi Vapor
LLC, the manufacturer of the premium BIDI®
Stick electronic nicotine delivery system (ENDS), announced today
that on Friday, October 22, 2021, FDA
issued an administrative stay, pursuant to 21 C.F.R. § 10.35, of
its Marketing Denial Order (MDO) for its non-tobacco flavored
BIDI® Sticks, pending the Agency's review
of the Company's request that the MDO be rescinded based on
product-specific scientific evidence in its Premarket Tobacco
Product Applications (PMTAs). FDA confirmed that while it reviews
Bidi Vapor's request, its flavored BIDI®
Sticks can remain on the market without the threat of
enforcement.
FDA Enters Administrative Stay of Bidi Vapor's Marketing Denial
Order for its Flavored ENDS
Prior to the court-ordered September 9,
2020, PMTA deadline and despite considerable business and
logistical challenges due to the COVID-19 pandemic, Bidi Vapor
submitted PMTAs for all 11 flavor varieties of its
BIDI® Stick, which is intended exclusively
for adult cigarette smokers and tobacco users, 21 and over. The
detailed applications ran over 285,000 pages and contained
significant information supporting the products as appropriate for
the protection of the public health (APPH). Despite submitting
scientifically rigorous PMTAs and keeping FDA informed about its
ongoing clinical and behavioral studies, Bidi Vapor received an MDO
for its flavored BIDI® Sticks, along with
nearly all other manufacturers of flavored ENDS, in early
September 2021.
On September 29, 2021, Bidi Vapor
filed a Petition for Review with the U.S. Court of Appeals for the
Eleventh Circuit, seeking judicial review of the MDO under the
Tobacco Control Act (TCA), the Administrative Procedure Act (APA),
as well as the U.S. Constitution. Accordingly, Bidi Vapor has
requested the appellate court to vacate the MDO, and provide such
additional relief as may be appropriate, including such relief as
necessary to ensure that Bidi may continue to market the products
subject to the MDO to its adult customers.
"We appreciate FDA's decision to stay, or put on hold, the MDO
as it reconsiders its denial. 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," said Niraj Patel, the Company's CEO.
"That said, we are still seeking a formal, judicial stay from
the appellate court pending the outcome of the lawsuit," Patel
noted.
The Company has now filed a Motion for Stay Pending Review with
the 11th Circuit Court of Appeals because of the continued
irreparable harm the MDO has caused. The stay motion summarizes how
FDA's actions were unlawful, as it was arbitrary and capricious, as
well as ultra vires, for FDA not to conduct any
scientific review of the PMTAs. FDA also violated due process and
the APA by failing to provide fair notice of the apparent
requirement for a specific-type of long-term study, which it had
previously indicated would not be required.
Regarding the litigation, Patel noted, "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."
Bidi Vapor remains committed to regulatory compliance and the
premarket review process and is forging ahead with its planned
studies to support its PMTAs. The Company's behavioral studies show
that the majority of BIDI® Stick consumers
are older smokers who were either able to transition completing
away from smoking or were able to significantly reduce the number
of daily cigarettes smoked. This corresponds with the Bidi
Vapor's completed clinical pharmacokinetic (PK) study, which will
soon be published, which demonstrates that the
BIDI® Sticks deliver nicotine to adult
consumers comparable to their usual cigarette brand and also
elicited similar subjective effects. In short, the behavioral
studies and PK study demonstrate that the
BIDI® Sticks may be a satisfying
alternative to cigarettes among current smokers and may support
their transitioning away from cigarette smoking.
"These study results are exciting, but we are continuing to
develop product-specific data to support the marketing of the
BIDI® Stick for adult smokers. A tough road
lies ahead, but we look forward to the challenge and working with
FDA to secure marketing authorization for our products," Patel
said.
ABOUT BIDI VAPOR
Based in Melbourne, Florida, Bidi Vapor maintains a
commitment to responsible marketing, supporting age-verification
standards and sustainability through its
BIDI® Cares recycling program. The
Company's premiere device, the BIDI® Stick,
is a premium product made with medical-grade components, a
UL-certified battery, and technology designed to deliver a
consistent vaping experience for adults 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 our mission, with the
BIDI® Stick promoting environmental
sustainability, while providing a unique vaping experience to adult
smokers.
For more information, visit www.bidivapor.com
ABOUT KAIVAL BRANDS
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. Our 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.
Learn more about Kaival Brands Innovations Group, Inc., at
www.ir.kaivalbrands.com.
Forward-Looking Statements
This press release includes statements that constitute
"forward-looking statements" within the meaning of federal
securities laws, which are statements other than historical facts
that frequently use 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 could materially 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, the
timing and results of the FDA's PMTA process; the scope of future
FDA enforcement of regulations in the ENDS industry; the FDA's
approach to the regulation of synthetic nicotine and its impact on
our business; the duration and scope of the COVID-19 pandemic and
impact on the demand for the products we distribute; the actions
governments, businesses, and individuals take in response to the
pandemic, including mandatory business closures and restrictions on
onsite commercial interactions; the impact of the pandemic and
actions taken in response to the pandemic on global and regional
economies and economic activity; the pace of recovery when the
COVID-19 pandemic subsides; general economic uncertainty in key
global markets and a worsening of global economic conditions or low
levels of economic growth; the effects of steps that we could take
to reduce operating costs; our inability to generate and sustain
profitable sales growth; 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; changes in government regulation or laws that affect
our business; significant changes in our relationships with our
distributors or sub-distributors; and those factors detailed by us
in our public filings with the Securities and Exchange Commission.
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.
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SOURCE Kaival Brands