22nd Century Group Applauds Califf Nomination as FDA Commissioner
November 15 2021 - 9:20AM
22nd Century Group, Inc. (Nasdaq: XXII), a leading
agricultural biotechnology company focused on tobacco harm
reduction, reduced nicotine tobacco, and improving health and
wellness through plant science, announced today that it strongly
supports the nomination of Dr. Robert Califf as the next
commissioner of the U.S. Food and Drug Administration (FDA). Califf
is known to be a longtime proponent of tobacco control and
supporter of the Agency’s Comprehensive Plan for Tobacco and
Nicotine Regulation.
“We are thrilled to hear that Dr. Califf has been nominated to
FDA’s top position as Commissioner. This is positive news for 22nd
Century Group as he is a longtime proponent of aggressive measures
to reduce the harm caused by smoking and is fully supportive of the
Agency’s plans to render all cigarettes ‘minimally or
non-addictive,’” said James A. Mish, chief executive officer of
22nd Century Group. “Califf has previously indicated that a
nicotine cap should be a key priority for the FDA. We look forward
to the implementation of a nicotine mandate – which we believe is
the single greatest opportunity to change the trajectory of public
health. Our reduced nicotine content cigarette, VLN®, is the only
combustible tobacco product that meets the nicotine levels proposed
in FDA’s nicotine mandate. We stand ready to support FDA on this
critical public health initiative.”
Califf was one of the FDA officials at the center of the
Agency’s plans for Tobacco and Nicotine Regulation under the Obama
Administration. In a 2019 blog post for the Association of American
Medical Colleges, Califf laid out his plans for regulating tobacco
products, including the requirement for the tobacco industry to
lower the amount of nicotine in its products to sub-addictive
levels levels using selective breeding, a feat 22nd Century has
already achieved in its VLN® product.
In recent months, Califf has directly urged the Biden
Administration to get tough on tobacco companies. During a March
panel discussion hosted by STAT, he stated: “Tobacco use is
becoming one of the most important markers of disparities in our
economy and our health care system. I hope that this administration
will have the courage to fight what will be tough battles.”
More than 16 million Americans are currently living with
diseases caused by smoking, and with every delay in action, even
more people will die from smoking. Introducing a nicotine cap could
significantly decrease the chances of youth becoming addicted to
cigarettes and could make it easier for currently addicted smokers
to quit.
Public health research projects that the enactment of a nicotine
cap at 0.5 mg of nicotine per gram of tobacco – a level already
achieved by 22nd Century’s VLN® reduced nicotine content tobacco
cigarette – would help more than five million people to quit
smoking within the first year of implementation, save more than
eight million American lives by the end of the century, and gain
more than 134 million life-years by 2100.
In support of the FDA’s plan, numerous independent scientific
studies, funded largely by the FDA, the National Institutes of
Health (NIH), and other U.S. federal government agencies, have
demonstrated that using reduced nicotine content tobacco cigarettes
helps smokers reduce their nicotine exposure and dependence, smoke
fewer cigarettes per day, increase their number of smoke-free days,
and double their quit attempts – all with minimal or no evidence of
nicotine withdrawal or compensatory smoking.
Securing MRTP designation for VLN® remains 22nd Century’s
highest priority. The Company held a successful meeting with the
FDA regarding its MRTP application October 14, 2021. Following the
meeting, and in conjunction with recent Center for Tobacco Products
(CTP) activity, the Company’s confidence in a positive outcome for
its MRTP application and timing is at its highest level to date.
22nd Century’s MRTP authorization and the launch of VLN® will serve
as a vanguard for the FDA’s proposed mandate to cap the levels of
nicotine in combustible cigarettes. The Company’s U.S. pilot
program and manufacturing capabilities are in place to launch VLN®
in the U.S. within 90 days of receiving MRTP designation.
Additionally, the Company is advancing its plans to launch VLN® in
select international markets beginning in the first quarter of
2022.
About 22nd Century Group, Inc.22nd Century
Group, Inc. (Nasdaq: XXII) is a leading agricultural
biotechnology company focused on tobacco harm reduction, reduced
nicotine tobacco and improving health and wellness through plant
science. With dozens of patents allowing it to control nicotine
biosynthesis in the tobacco plant, the Company has developed
proprietary reduced nicotine content (RNC) tobacco plants and
cigarettes, which have become the cornerstone of the FDA’s
Comprehensive Plan to address the widespread death and disease
caused by smoking. In tobacco, hemp/cannabis, and hop plants, 22nd
Century uses modern plant breeding technologies, including genetic
engineering, gene-editing, and molecular breeding to deliver
solutions for the life science and consumer products industries by
creating new, proprietary plants with optimized alkaloid and
flavonoid profiles as well as improved yields and valuable
agronomic traits.
Learn more at xxiicentury.com,
on Twitter @_xxiicentury, and on LinkedIn.
Cautionary Note Regarding Forward-Looking
StatementsExcept for historical information, all of the
statements, expectations, and assumptions contained in this press
release are forward-looking statements. Forward-looking statements
typically contain terms such as “anticipate,” “believe,”
“consider,” “continue,” “could,” “estimate,” “expect,” “explore,”
“foresee,” “goal,” “guidance,” “intend,” “likely,” “may,” “plan,”
“potential,” “predict,” “preliminary,” “probable,” “project,”
“promising,” “seek,” “should,” “will,” “would,” and similar
expressions. Actual results might differ materially from those
explicit or implicit in forward-looking statements. Important
factors that could cause actual results to differ materially are
set forth in “Risk Factors” in the Company’s Annual Report on Form
10-K filed on March 11, 2021. All information provided in this
release is as of the date hereof, and the Company assumes no
obligation to and does not intend to update these forward-looking
statements, except as required by law.
Investor Relations & Media Contact:Mei
KuoDirector, Communications & Investor Relations22nd Century
Group, Inc.(716) 300-1221mkuo@xxiicentury.com
22nd Century (NASDAQ:XXII)
Historical Stock Chart
From Mar 2024 to Apr 2024
22nd Century (NASDAQ:XXII)
Historical Stock Chart
From Apr 2023 to Apr 2024