22nd Century Group (XXII) Supports FDA Policy Advancements, Proposed Menthol Ban Now at OMB
26 Oktober 2023 - 2:30PM
22nd Century Group, Inc. (Nasdaq: XXII), a leading biotechnology
company focused on utilizing advanced plant technologies to improve
health and wellness with reduced nicotine tobacco, hemp/cannabis
and hops, announced that it supports the recent move by the US Food
and Drug Administration to send final rules aimed at banning
menthol in cigarettes and banning flavored cigars to the White
House Office of Management and Budget for review, a key regulatory
step toward the rules becoming federal policy.
In April 2022, the FDA stated that these
proposed policies had the potential to reduce disease and death
associated with smoking and support smoking cessation. Stop smoking
experts largely agree such policies could save lives and mitigate
the creation of new smokers, as well as help to address racial
disparities in the harms of smoking. The policy submissions,
originally expected earlier this year, are more than a decade in
the making. The FDA officially began exploring the concept of a
menthol ban in July 2013.
FDA’s April 28, 2022 press release announcing
its rule making stated that the proposed menthol standard will
“reduce the appeal of cigarettes, particularly to youth and young
adults, decreasing the likelihood that nonusers who would otherwise
experiment with menthol cigarettes would progress to regular
smoking” and “improve the health and reduce the mortality risk of
current menthol cigarette smokers by decreasing cigarette
consumption and increasing the likelihood of cessation.”
Tobacco use is widely regarded as the number one
cause of preventable death in the US, and menthol cigarettes are
widely documented to increase the addictive nature of cigarette
smoking, as well as target minority communities. Flavored cigar
products are known to be particularly appealing to youth and have
been shown to be popular among younger or underage smokers.
“The FDA has taken a significant step forward to
enact federal enforcement on these important public health
policies,” said John Miller, Interim Chief Executive Officer of
22nd Century Group. “The FDA has closely studied these issues for
years, accumulating a wealth of scientific and clinical research
data in support of these advances. Submission of the FDA’s
proposals to the OMB is a key step ahead of publishing the final
rules, which we believe could be the most transformative proactive
public health policies of a generation. We are eager to see the
final rules, and how FDA proposes to handle products with modified
risk designations, which are designed to reduce the harms
associated with smoking.”
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. The Company received the first
and only FDA Modified Risk Tobacco Product (MRTP) authorization for
a combustible cigarette in December 2021. 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,
on LinkedIn, and on YouTube.
Learn more about
VLN® at tryvln.com.
Cautionary Note Regarding Forward-Looking
Statements
Except 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 9, 2023. 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 ContactMatt
KrepsInvestor Relations22nd Century
Groupmkreps@xxiicentury.com214-597-8200
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