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22nd Century’s New Study Confirms Very Low Nicotine Content Cigarettes Result in 97% Less Nicotine in Smoker’s Bloodstream

WILLIAMSVILLE, N.Y.--(BUSINESS WIRE)--

22nd Century Group, Inc. (NYSE American:XXII), a plant biotechnology company that is focused on tobacco harm reduction and hemp/cannabis research, announced today the results of a recently completed, company-sponsored study involving 22nd Century’s Very Low Nicotine Content (VLNC) cigarettes. The results indicate that subjects using the VLNC product had 97% less nicotine in their blood as compared to their blood-nicotine levels after use of their usual brand of highly addictive commercial cigarettes.

22nd Century’s important new study was included in the Company’s Modified Risk Tobacco Product (MRTP) application, which was previously submitted to the U.S. Food and Drug Administration (FDA) for 22nd Century’s VLNC cigarettes under the proposed brand name VLN™. 22nd Century’s MRTP application seeks the FDA’s authorization to advertise that VLN™ cigarettes contain 95% less nicotine as compared to the 100 top-selling cigarette brands in the United States.

Nicotine has long been known as the primary addictive chemical in cigarettes. 22nd Century’s VLN™ cigarettes, with 95% less nicotine, have greatly diminished nicotine exposure versus conventional cigarettes that contain highly addictive levels of nicotine. In the recently completed study, 55 subjects were randomly assigned to each of the following three products on different days of the study: 1) their usual brand of cigarettes (containing addictive levels of nicotine), 2) the Company’s VLN™ cigarettes (containing 95% less nicotine than users’ usual brands of cigarettes), and 3) nicotine chewing gum. The subjects were allowed to use each of the products, as much as desired, on different days of the study; subsequently, after each day of using one of the three products, each participant’s blood-nicotine level was tested.

When the subjects used VLN™ cigarettes, the nicotine level in their blood was 97% less than the nicotine level in their blood when they used their usual brand of cigarettes. In contrast, when the subjects used nicotine gum, which is a common nicotine replacement therapy, the users’ nicotine level in their blood was only 69% less than when they used their usual brand of cigarettes.

The study results also showed that the users’ cravings for cigarettes and urge to smoke were significantly reduced. Overall, the results of 22nd Century’s study suggest that (i) VLN™ cigarettes have a lower potential for abuse than conventional cigarettes, and (ii) VLN™ cigarettes have a potential for abuse that may be comparable to using nicotine gum.

“In contrast to the highly addictive cigarettes sold by Big Tobacco companies, 22nd Century’s VLN™ cigarettes contain 95% less nicotine,” explained Henry Sicignano III, President and Chief Executive Officer of 22nd Century Group. “22nd Century’s new study joins more than 50 independent scientific studies using our Company’s proprietary VLNC tobacco and investigating the potential public health benefits of VLNC cigarettes. Upon FDA approval, we look forward to bringing to market the world’s first Modified Risk Tobacco Product."

About 22nd Century Group, Inc.

22nd Century is a plant biotechnology company focused on technology which allows it to increase or decrease the level of nicotine in tobacco plants and the level of cannabinoids in hemp/cannabis plants through genetic engineering and plant breeding. The Company’s primary mission in tobacco is to reduce the harm caused by smoking. The Company’s primary mission in hemp/cannabis is to develop proprietary hemp/cannabis strains for important new medicines and agricultural crops. Visit www.xxiicentury.com and www.botanicalgenetics.com for more information.

Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking information, including all statements that are not statements of historical fact regarding the intent, belief or current expectations of 22nd Century Group, Inc., its directors or its officers with respect to the contents of this press release, including but not limited to our future revenue expectations. The words “may,” “would,” “will,” “expect,” “estimate,” “anticipate,” “believe,” “intend” and similar expressions and variations thereof are intended to identify forward-looking statements. We cannot guarantee future results, levels of activity or performance. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that we may issue in the future. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances, or to reflect the occurrence of unanticipated events. You should carefully review and consider the various disclosures made by us in our annual report on Form 10-K for the fiscal year ended December 31, 2018, filed on March 6, 2019, including the section entitled “Risk Factors,” and our other reports filed with the U.S. Securities and Exchange Commission which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, our actual results may vary materially from those expected or projected.

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