22nd Century Group Installs State-of-the-Art Nicotine Testing Equipment to Enhance VLN® Production
06 May 2021 - 12:06AM
22nd Century Group, Inc. (NYSE American: XXII), a leading
plant-based biotechnology company focused on tobacco harm
reduction, reduced nicotine tobacco, and hemp/cannabis research,
announced today that it is advancing and expanding capabilities in
its in-house laboratory, located in its cigarette manufacturing
facility in Mocksville, North Carolina, for testing of its VLN®
reduced nicotine content (RNC) tobacco and cigarettes. The Company
estimates that its cost per VLN® sample will improve by more than
90% and the lead time for key data will take less than a day
compared to using a third-party testing service that can take
weeks.
“This is an important investment and milestone for 22nd Century,
as it is imperative to the launch of VLN® and the future of the
organization that we have the ability to rapidly conduct
high-precision analysis of our own products at higher testing
volumes,” says James A. Mish, chief executive officer of 22nd
Century Group. “With these expanded capabilities in place, we have
a fully integrated business unit, able to monitor and control the
results from growing, blending, and manufacturing of our reduced
nicotine content cigarettes. In addition, by having the entire
testing process managed within 22nd Century, it will improve
testing consistency and give us greater ability to manage product
quality in-house. By making this investment now, we will be
well-positioned for the FDA’s authorization of our Modified Risk
Tobacco Product (MRTP) application to market our VLN® cigarettes to
the public.”
22nd Century now has the same lab testing equipment and
capabilities as outside facilities. The Company is also working
toward receiving ISO/IEC 17025 accreditation, which grants
international recognition of an organization’s commitment to
quality, competency, and reliable results. This accreditation
demonstrates to customers and industry that 22nd Century has the
technical competence to provide reliable and accurate test results
even at the lowest nicotine levels. The new laboratory is starting
operations at an opportune time, as earlier this year 22nd Century
announced that it has significantly expanded its tobacco growing
program to support the anticipated demand for its VLN®
cigarettes.
“As we start to receive tobacco from growers, we will be able to
test every bale of tobacco in-house to ensure that it meets the
stringent requirements established by 22nd Century. We will now
receive test results much faster and at lower cost, which will help
us to better meet the expected demand for our product,” says
Michael Zercher, chief operating officer at 22nd Century.
Made from proprietary tobacco engineered to contain 95% less
nicotine than conventional cigarette tobacco, 22nd Century’s RNC
cigarettes are the only combustible tobacco products able to meet
the nicotine levels proposed in the FDA’s Advance Notice of
Proposed Rulemaking (ANPRM) for a tobacco product standard that
requires all combustible cigarettes to contain “minimally or
non-addictive” levels of nicotine. 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.
The Company is highly confident that its MRTP application for
VLN® is in the final stages of the FDA’s review process. This
important designation will allow 22nd Century to communicate key
features of VLN® King and VLN® Menthol King, including a
headline claim of “95% less nicotine.” Although VLN® contains
just 0.5 milligrams of nicotine per gram of tobacco,
VLN® tastes, smells, and smokes like a conventional cigarette.
This disruptive product is an innovative alternative to addictive,
conventional cigarettes and will help adult smokers reduce their
exposure to nicotine. 22nd Century is fully prepared and eager to
launch its VLN® cigarettes within 90 days of receiving
authorization from the FDA and believes that a MRTP designation
will serve as a catalyst for its VLN® brand and tobacco
franchise. The Company remains willing to license its RNC tobacco
technology to every cigarette manufacturer, including Altria,
Reynolds American, and other Big Tobacco companies, so that the
entire industry can join 22nd Century’s effort to reduce the harm
caused by smoking and protect future generations from ever becoming
addicted to cigarettes.
About 22nd Century Group, Inc.22nd Century
Group, Inc. (NYSE American: XXII) is a leading plant biotechnology
company focused on technologies that alter the level of nicotine in
tobacco plants and the level of cannabinoids in hemp/cannabis
plants through genetic engineering, gene-editing, and modern plant
breeding. 22nd Century’s primary mission in tobacco is to reduce
the harm caused by smoking through the Company’s proprietary
reduced nicotine content tobacco cigarettes – containing 95% less
nicotine than conventional cigarettes. The Company’s primary
mission in hemp/cannabis is to develop and commercialize
proprietary hemp/cannabis plants with valuable cannabinoid profiles
and desirable 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
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