Company Announcements

BUFFALO, N.Y., Oct. 26, 2023 (GLOBE NEWSWIRE) -- 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.

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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 Contact
Matt Kreps
Investor Relations
22nd Century Group
mkreps@xxiicentury.com
214-597-8200